An Integrated Pharmacokinetic and Safety Open-label Basket Trial of Daprodustat for the Treatment of Anemia Associated With Chronic Kidney Disease in Male and Female Children and Adolescents Aged 3 Months to Under 18 Years Requiring or Not Requiring Dialysis

This is an international, multicenter trial, evaluating pharmacokinetics (PK) (4 weeks), safety (52 weeks), and hemoglobin (Hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated with chronic kidney disease (CKD) incorporating 2 independent sub-trials (Non dialysis [ND] and Dialysis [D]). This study will enroll participants with anemia associated with CKD, in 2 distinct sub-populations differing only by their CKD stage and dialysis requirement (ND: CKD stage 3 to 5 not yet receiving dialysis and D: CKD stage 5d undergoing peritoneal dialysis [PD] or hemodialysis [HD]).
The maximum duration of the study will be approximately 60 weeks, including Screening period (up to 4 weeks), treatment period (52 weeks), and follow-up period (4 weeks).
Outcome measures are identical for the ND and D sub-trials, but will be separately assessed in each sub- trials, overall and within each age subgroups (12 to less than [<] 18 years, 6 to <12 years, 2 to <6 years, and 3 months to <2 years). Except for PK and dose change, which is within each age group only.

Start Date06 Sep 2023

Sponsor / Collaborator

GSK Plc

EUCTR2021-002013-34-AT / Unknown statusPhase 3

An Integrated Pharmacokinetic and Safety Open-label Basket Trial of Daprodustat for the Treatment of Anemia Associated with Chronic Kidney Disease in Male and Female Children and Adolescents Aged 3 Months to Under 18 Years Requiring or Not Requiring Dialysis. - ASCEND-P

Start Date01 Aug 2023

Sponsor / Collaborator

GlaxoSmithKline Research & Development Ltd.

NCT05951192 / CompletedPhase 4IIT

A Prospective Interventional Study Assessing the Clinical and Operational Effectiveness of Transitioning From Mircera to Daprodustat for the Treatment of Anemia in End Stage Kidney Disease

Investigator-initiated, interventional, prospective study to assess the clinical and operational effectiveness of daprodustat in adult patients receiving in center hemodialysis or peritoneal home dialysis who are transitioning from Mircera to daprodustat.

Start Date01 Jul 2023

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Daprodustat

100 Translational Medicine associated with Daprodustat

100 Patents (Medical) associated with Daprodustat

Literatures (Medical) associated with Daprodustat

04 Jan 2024·Clinical kidney journal

Comparison of outcomes on hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) in anaemia associated with chronic kidney disease: network meta-analyses in dialysis and non-dialysis dependent populations

Article

Author: Dasgupta, Indranil ; Keeley, Tom J ; Ballew, Nick ; Johansen, Kirsten L ; Camejo, Rodrigo Refoios ; Sutton, Alexander J ; Cases, Aleix ; Sackeyfio, Alfred ; Ayyagari, Rajeev ; Kovesdy, Csaba P ; Lopes, Renato D ; Mallett, Steve A ; Garcia-Horton, Viviana

ABSTRACT:

Background:

Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) are oral alternatives to current standard-of-care treatments for anaemia in chronic kidney disease (CKD). We conducted network meta-analyses to indirectly compare clinical outcomes for three HIF-PHIs in dialysis and non-dialysis populations with anaemia in CKD.

Methods:

The evidence base comprised phase III, randomised, controlled trials evaluating daprodustat, roxadustat, or vadadustat. Three outcomes were evaluated: efficacy [change from baseline in haemoglobin (Hgb)], cardiovascular safety [time to first major adverse cardiovascular event (MACE)] and quality of life [change from baseline in 36-Item Short Form Health Survey (SF-36) Vitality score]. Analyses were performed separately for all patients and for erythropoiesis-stimulating agent (ESA) non-users at baseline (non-dialysis population) or prevalent dialysis patients (dialysis population). Bayesian Markov Chain Monte Carlo methods with non-informative priors were used to estimate the posterior probability distribution and generate pairwise treatment comparisons. Point estimates (medians of posterior distributions) and 95% credible intervals (CrI) were calculated.

Results:

Seventeen trials were included. In non-dialysis patients, there were no clinically meaningful differences between the three HIF-PHIs with respect to Hgb change from baseline [all patients analysis (total n = 7907): daprodustat vs. roxadustat, 0.09 g/dL (95% CrI −0.14, 0.31); daprodustat vs. vadadustat, 0.09 g/dL (−0.04, 0.21); roxadustat vs. vadadustat, 0.00 g/dL (−0.22, 0.22)] or risk of MACE [all patients analysis (total n = 7959): daprodustat vs. roxadustat, hazard ratio (HR) 1.16 (95% CrI 0.76, 1.77); daprodustat vs. vadadustat, 0.88 (0.71, 1.09); roxadustat vs. vadadustat, 0.76 (0.50, 1.16)]. Daprodustat showed a greater increase in SF-36 Vitality compared with roxadustat [total n = 4880; treatment difference 4.70 points (95% CrI 0.08, 9.31)]. In dialysis patients, Hgb change from baseline was higher with daprodustat and roxadustat compared with vadadustat [all patients analysis (total n = 11 124): daprodustat, 0.34 g/dL (0.22, 0.45); roxadustat, 0.38 g/dL (0.27, 0.49)], while there were no clinically meaningful differences in the risk of MACE between the HIF-PHIs [all patients analysis (total n = 12 320): daprodustat vs. roxadustat, HR 0.89 (0.73, 1.08); daprodustat vs. vadadustat, HR 0.99 (0.82, 1.21); roxadustat vs. vadadustat, HR 1.12 (0.92, 1.37)]. Results were similar in analyses of ESA non-users and prevalent dialysis patients.

Conclusions:

In the setting of anaemia in CKD, indirect treatment comparisons suggest that daprodustat, roxadustat, and vadadustat are broadly clinically comparable in terms of efficacy and cardiovascular safety (precision was low for the latter), while daprodustat may be associated with reduction in fatigue to a greater extent than roxadustat.

01 Jan 2024·Internal medicine (Tokyo, Japan)

The Comparison between Vadadustat and Daprodustat Regarding Dose, Cost, and Safety of Treatment for Renal Anemia in Non-dialysis Patients with Chronic Kidney Diseases

Article

Author: Imai, Atsuhiro ; Imai, Enyu

Objective We retrospectively compared the dose, cost, and safety of vadadustat and daprodustat for the treatment of renal anemia in patients with chronic kidney diseases who were not undergoing dialysis. Methods The primary outcome of this study was the change in dose and cost from the initiation of vadadustat and daprodustat treatment. The secondary outcome was the drug safety. Patients We treated 30 patients each with the hypoxia-inducible factor prolyl-hydroxylase inhibitors (HIF-PHIs) daprodustat and vadadustat. The hemoglobin (Hb) concentration was targeted at 11-13 g/dL, and transferrin saturation was maintained at ≥20%, as per the 2018 Japanese guidelines for the diagnosis and treatment of chronic kidney disease. Results Hb levels increased from 10.7 to 11.5 g/dL after the first month of daprodustat administration, whereas those for vadadustat patients remained relatively stable, going from 10.7 to 10.6 g/dL. After six months, the Hb level reached 12.1 g/dL and 11.3 g/dL for daprodustat and vadadustat, respectively. The dosage of vadadustat was significantly increased by 46% and 70% after 3 and 12 months, respectively, compared with the initial doses, whereas that of daprodustat did not change substantially. The average cost of vadadustat also increased in the first 3 months and remained over 500 yen/day after 3 months, while that of daprodustat showed little change from the initial cost of 360 yen/day. Conclusion These results suggest that heterogeneity exists in the drug potency and dosage required for treatment between daprodustat and vadadustat. Serious adverse events (death, cardiovascular disease, end stage renal disease (ESRD), and malignancy) occurred in more than 20% of participants with both HIF-PHIs. Further studies are required to confirm the safety of HIF-PHIs.

01 Jan 2024·iScience

Hypoxia inducible factors inhibit respiratory syncytial virus infection by modulation of nucleolin expression

Article

Author: Kipar, Anja ; Borrmann, Helene ; Sharma, Parul ; Bentley, Eleanor ; McKeating, Jane A ; Balfe, Peter ; Bailey, Dalan ; Zhuang, Xiaodong ; Tsukuda, Senko ; Wing, Peter A C ; Kirby, Adam ; Magri, Andrea ; Harris, Adrian L ; Harris, James M ; Gallo, Giulia ; Stewart, James P ; Matthews, David ; Ha, Jiyeon ; de Neck, Simon ; Yang, Hongbing

Respiratory syncytial virus (RSV) is a global healthcare problem, causing respiratory illness in young children and elderly individuals. Our knowledge of the host pathways that define susceptibility to infection and disease severity are limited. Hypoxia inducible factors (HIFs) define metabolic responses to low oxygen and regulate inflammatory responses in the lower respiratory tract. We demonstrate a role for HIFs to suppress RSV entry and RNA replication. We show that hypoxia and HIF prolyl-hydroxylase inhibitors reduce the expression of the RSV entry receptor nucleolin and inhibit viral cell-cell fusion. We identify a HIF regulated microRNA, miR-494, that regulates nucleolin expression. In RSV-infected mice, treatment with the clinically approved HIF prolyl-hydroxylase inhibitor, Daprodustat, reduced the level of infectious virus and infiltrating monocytes and neutrophils in the lung. This study highlights a role for HIF-signalling to limit multiple aspects of RSV infection and associated inflammation and informs future therapeutic approaches for this respiratory pathogen.

News (Medical) associated with Daprodustat

31 Mar 2024

·medcitynews.com

Akebia Recovers From Rejection to Win FDA Approval for Anemia Drug

An Akebia Therapeutics drug for a type of anemia has won FDA approval, a regulatory decision that comes nearly two years after the agency rejected the drug due to safety concerns. Safety remains a concern about the small molecule, vadadustat. The drug’s label carries a black box warning about an increased risk of death from a variety of cardiovascular complications. But the Akebia product, which will be branded as Vafseo, now introduces a new treatment option for the estimated 500,000 adults in the U.S who suffer from anemia due to chronic kidney disease (CKD). To use this drug, patients must have been receiving dialysis for at least three months. Anemia develops when there aren’t enough healthy red blood cells to carry oxygen to tissues in the body. It’s common in chronic kidney disease patients because their kidneys do not produce enough erythropoietin, a hormone that helps regulate red blood cell production. This anemia can be treated with erythropoietin-stimulating agents, engineered versions of the hormone administered as chronic injections. Akebia’s Vafseo offers more convenient oral dosing. This drug belongs to a class of drugs called hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitors. By mimicking the effects of high altitude on the body, these drugs get the body to produce erythropoietin. When the FDA rejected this drug in 2022, it flagged cardiovascular risks and asked Akebia to run another clinical trial. Instead, the company resubmitted an application with additional post-marketing safety data from Japan, where the drug has been used since its approval there in 2020. Vafseo will compete against GSK’s Jesduvroq, which last year became the first FDA-approved oral medication for anemia caused by CKD. Jesduvroq is limited to patients who have been on dialysis for at least four months. Similar to Akebia’s drug, Jesduvroq’s label carries a black box warning for cardiovascular risks. Akebia said it will commercialize Vafseo in the U.S. with its established commercial team, which has renal experience and a relationship with CSL Vifor, the kidney disease-focused company that is the product of CSL Limited’s 2021 acquisition of Vifor Pharma. Here’s a recap of other recent regulatory news: —Winrevair, the pulmonary arterial hypertension (PAH) drug that was the centerpiece of an $11.3 billion Merck acquisition, won FDA approval. The PAH drugs already available treat symptoms. Winrevair is the first drug that addresses an underlying cause of this disorder affecting heart and lung function. —In other PAH news, the FDA approved Johnson & Johnson’s Opsynvi. This drug combines two older PAH drugs, macitentan and taladifil. Macitentan blocks the endothelin receptor while taladifil is a phosphodiesterase 5 inhibitor. Addressing both pathways requires patients to take multiple pills. Opsynvi is the first drug that combines both mechanisms in a single once-daily pill. —AstraZeneca’s drug Ultomiris added neuromyelitis optica spectrum disorder (NMOSD) as a new indication for the blockbuster drug. NMOSD is an autoimmune disease affecting the central nervous system, including the spine and optic nerves. Ultomiris blocks C5, a protein of the complement system, a part of the immune system. The drug has approvals for treating several other rare, complement system disorders. —Metabolic dysfunction-associated steatohepatitis (MASH), a fatty liver disease that affects as many as 7 million Americans, now has its first approved drug. The FDA gave the green light to Rezdiffra, a Madrigal Pharmaceuticals’ medication that posted clinical trial results showing it can reverse the liver scarring that is characteristic of the disorder. Madrigal’s once-daily pill carries an annual wholesale price of $47,400. —An Italfarmaco drug for Duchenne muscular dystrophy won FDA approval for treating all patients who have the inherited muscle-wasting disorder, regardless of the genetic variant driving their disease. Corticosteroids are a standard first-line therapy for Duchenne. The Italfarmaco drug, Duvyzat, is the first nonsteroidal therapy approved for the disease. —Orchard Therapeutics gene therapy Lenmeldy is now the first FDA-approved treatment for metachromatic leukodystrophy (MLD), a rare enzyme deficiency. Lenmeldy is made by modifying a patient’s hematopoietic stem cells to carry a functional gene that codes for the deficient enzyme. Orchard is now part of Japanese drugmaker Kyowa Kirin following a $387 million acquisition announced last year. —Regeneron Pharmaceuticals’ drug odronextamab was turned down by the FDA for two indications: follicular lymphoma and diffuse large B-cell lymphoma. According to Regeneron, the agency did not flag any safety, efficacy, or manufacturing issues for the bispecific antibody. The FDA told Regeneron it cannot resubmit applications until confirmatory studies are underway and completion timelines are agreed upon. Regeneron said it will share updates on enrollment and regulatory timelines later this year. The drug is still under regulatory review in Europe. —The FDA awarded full approval to AbbVie ovarian cancer drug Elahere. The antibody drug conjugate developed by ImmunoGen won accelerated approval in 2022. AbbVie acquired ImmunoGen last year in a $10.1 billion deal. —Invivyd antibody drug Pemgarda was granted emergency use authorization for prevention of Covid-19 in adults and adolescents with moderate-to-severe compromised immune systems. Other Covid-19 antibody drugs have had their authorizations revoked as they proved ineffective against new variants. Pemgarda comes from an Invivyd platform technology designed to address rapid viral evolution. —Idorsia Pharmaceuticals’ aprocitentan, brand name Tryviao, received FDA approval for treating hypertension when used in combination with other antihypertension drugs. The once-daily pill is designed to block the endothelin receptor. It’s the first approved high blood pressure drug with this mechanism of action. —Takeda Pharmaceutical drug Iclusig is now FDA approved for treating Philadelphia chromosome-positive acute lymphoblastic leukemia when used in combination with chemotherapy. The once-daily pill works by blocking enzymes associated with cancer growth. The accelerated approval adds to the list of indications for the drug, which is used to treat three types of leukemia. —The European Commission granted marketing authorization to Prevnar 20 for preventing pneumococcal disease in infants and children. The conjugate vaccine, which is designed to protect against the 20 circulating strains responsible for most pneumococcal infections, won European approval for adults in 2022. Prevnar 20 was first approved by the FDA for adults in 2021 and for children last year. —BeiGene cancer immunotherapy Tevimbra received a long-awaited FDA approval for treating adults with advanced esophageal squamous cell carcinoma. The FDA decision expected in 2022 was delayed by Covid-19. Though the drug received European Commission approval last year, BeiGene lost Novartis as a partner on the cancer therapy along the way. BeiGene said it expects Tevimbra, part of the class of drugs known as checkpoint inhibitors, will become available in the U.S. in the second half of this year. —Mirum Pharmaceuticals drug Livmarli landed FDA approval for treating pruritus, or severe itching, caused by the rare liver disease progressive familial intrahepatic cholestasis (PFIC). The approval cover patients age 5 and older. The company has also submitted an application seeking approval of a higher concentration formulation for treating younger PFIC patients. Livmarli was first approved by the FDA in 2021 as a treatment for pruritus caused by Alagille syndrome. Public domain image by Flickr user SciTechTrend

Drug ApprovalImmunotherapyAcquisitionVaccine

28 Mar 2024

·www.fiercepharma.com

Akebia's Vafseo finally gets its shot at US chronic kidney disease market after FDA approval

After a rocky two years following the FDA's initial rejection of Vafseo, Akebia can finally treat a portion of U.S. patients with anemia from chronic kidney disease. Akebia never lost confidence in its oral chronic kidney disease (CKD) anemia drug Vafseo, even after the FDA nixed its first approval bid two years ago with a complete response letter. Now, the company finally can celebrate a long-awaited U.S. approval. The FDA on Wednesday cleared Vafseo for patients with CKD-associated anemia who have been receiving dialysis for at least three months, kicking off a market showdown between Akebia and GSK. Thanks to a resubmission that included additional safety data from patients in Japan, where the drug has been marketed since 2020, the agency reconsidered its prior concern about potential liver toxicity. For the past two years, Akebia has been doing “everything we have to do” as a company to survive, CEO John Butler said in a recent interview with Fierce Pharma. That included laying off about half its staff and focusing on its lone commercial asset, CKD med Auryxia. The long road to approval The story of Vafseo, from Butler’s perspective, goes something like this: The FDA took issue with the potential for drug-induced liver injury, which Akebia disputed. In fact, the company felt so strongly that the agency made the wrong call that it initiated a formal dispute resolution process. Besides trial results, Akebia was armed with real-world data from Japan, where Mitsubishi Tanabe Pharma is handling commercialization of Vafseo. Japan specifically conducts “outstanding” post-marketing surveillance on its approved meds and hasn’t found any severe instances of drug-induced liver injury, bolstering the drugmaker’s confidence in its safety profile, according to Butler. Vafseo offers a different way to manage anemia than traditional erythropoiesis-stimulating agents, Butler explained. The drug, a hypoxia-inducible factor–prolyl hydroxylase inhibitor (HIF-PHI), works through a unique technique of basically fooling the body into believing it's at a high altitude, effectively encouraging the bone marrow to produce more red blood cells. Vafseo would have been a first-in-class therapy if not for the two-year delay. Instead, that title went to GSK and its Jesduvroq, which was approved in February 2023. The rival also launched strictly in the dialysis-dependent patient population, much to GSK’s disappointment. In July, GSK revealed its decision to not commercialize the med in Europe, despite winning support from the region’s drug evaluation committee the previous month. The company snatched back its application in Europe and opted to not seek approval in other countries based on the shrunken market opportunity that came without the non-dialysis population. Still, Jesduvroq’s presence in the U.S. market requires Akebia to adapt its original launch strategy, Butler acknowledged. A turnaround from hard times The FDA nod promises to be “transformational" for the company, the CEO said. After two years of scraping by, Akebia can finally dip its toes in the sizable market for CKD anemia. However, unlike the drug's broad label in Japan, Akebia won't be able to reach the non-dialysis population—at least for now. Beyond Vafseo, Akebia also looks to build on its pipeline, which already includes two preclinical compounds for acute kidney injury and blindness in newborn babies, or retinopathy of prematurity. All of that work will be done with a markedly smaller workforce than Akebia once had. Shortly after the original FDA rejection, the company had to cut about $60 million to $65 million in annual costs by letting go of 200 staffers, or 42% of its prior headcount. Following the job cuts, the FDA dispute resolution process began in October of 2022 and finally resulted in “a path forward” last May. “You know, you build culture for the hard times, and these were hard times, but people persevered and the light is very bright at the end of the tunnel,” Butler said. Since 2017, CSL Vifor has held the U.S. license to sell the med to Fresenius Medical Care dialysis centers nationwide. That $50 million deal was expanded in 2022 shortly before the FDA’s first decision, allowing Vifor to market Vafseo to “certain third-party dialysis organizations" responsible for treating 60% of U.S. dialysis patients. Akebia looks to launch Vafseo with the intention to “become a new oral standard of care” for dialysis patients, the company noted in its press release. Today, most patients are currently treated with standard injectable erythropoiesis-stimulating agents. With the U.S. nod, the med is now approved in 37 countries.

Drug Approval

28 Mar 2024

·www.biopharmadive.com

FDA approves Akebia anemia pill, two years after rejection

Dive Brief:The Food and Drug Administration has approved Akebia Therapeuticsblood-boosting pill Vafseo for people with anemia from chronic kidney disease, the company said Wednesday, reversing a rejection the agency made two years ago over the drugs safety.The decision came after a review of safety data from Japan, where Vafseo has been used since 2020, in addition to clinical trials Akebia completed before its initial application. Last year, the regulator approved a similarly acting pill called Jesduvroq from GSK with extensive safety restrictions and warnings.Vafseo can only be used in kidney disease patients who have been on dialysis at least three months. The label includes a black box warning about the risk of cardiovascular complications from blood clots, stating there is no dose, dosing protocol or level of hemoglobin that doesnt increase the risk.Dive Insight:Drug developers have studied pills like Jesduvroq and Vafseo as alternatives to injectable biologic drugs like Amgens Epogen in the hopes they would be safer and more convenient. Rather than mimicking a natural blood-boosting protein called erythropoietin as the biologics do, Jesduvroq and Vafseo trick the body into responding as if it were in a high-altitude environment by blocking a protein called HIF-PH. That, in turn, stimulates red blood cell production.But the FDA has viewed the pills as no safer than biologics, stating in the black box warning that targeting a hemoglobin level above 11 grams per deciliter with Vafseo adds similar risk as with the biologics. Normal hemoglobin levels are 12 to 16 for women and 14 to 18 for men.Doctors using Vafseo should use a low dose that can reduce the need for blood transfusions, the FDA said.The FDAs initial rejection of Vafseo prompted Akebia to lay off 42% of its workers in a restructuring that reoriented the company around marketing its approved drug Auryxia, an iron replacement and phosphorus control agent for people with anemia from chronic kidney disease.Akebia got a lifeline when the FDA approved Jesduvroq and then accepted a resubmission for Vafseo, known scientifically as vadadustat. With the Jesduvroq approval and the Vafseo resubmission, the agency only considered use for patients on dialysis, as recommended by FDAs outside experts, and not those patients whose disease hadnt progressed enough to need dialysis.The outlook for these drugs in only dialysis patients is unclear. GSK reported sales of only 26 million pounds, or about $33 million, for Jesduvroq in its annual report for 2023.Akebia shares fell by double digits in morning trading Thursday. '

Drug ApprovalAccelerated Approval

100 Deals associated with Daprodustat

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D10874	-	-	DB11682

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
chronic renal failure anemia	US	GSK Plc	01 Feb 2023
chronic renal failure anemia	US	GlaxoSmithKline Intellectual Property (No. 2) Ltd.	01 Feb 2023
Anemia in chronic kidney disease	JP	GSK Plc	29 Jun 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Anemia	NDA/BLA	EU	GSK Plc	01 Mar 2022
Aspergillosis, Allergic Bronchopulmonary	Phase 3	US	GSK Plc	28 Sep 2016
Aspergillosis, Allergic Bronchopulmonary	Phase 3	AR	GSK Plc	28 Sep 2016
Aspergillosis, Allergic Bronchopulmonary	Phase 3	AU	GSK Plc	28 Sep 2016
Aspergillosis, Allergic Bronchopulmonary	Phase 3	AT	GSK Plc	28 Sep 2016
Aspergillosis, Allergic Bronchopulmonary	Phase 3	BE	GSK Plc	28 Sep 2016
Aspergillosis, Allergic Bronchopulmonary	Phase 3	BR	GSK Plc	28 Sep 2016
Aspergillosis, Allergic Bronchopulmonary	Phase 3	BG	GSK Plc	28 Sep 2016
Aspergillosis, Allergic Bronchopulmonary	Phase 3	CA	GSK Plc	28 Sep 2016
Aspergillosis, Allergic Bronchopulmonary	Phase 3	CZ	GSK Plc	28 Sep 2016

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03457701 (CTgov)	Phase 2	Anemia \| Chronic Kidney Diseases	15	Daprodustat (Daprodustat)	aqazdicnck(cjhkbakyyd) = mciisblpjh gtnqaqzodn (zddeipajft, latoallxcb - mqbolezpob) View more	-	25 Jul 2023
				darbepoetin alfa+ferrous sulfate (rhEPO)	aqazdicnck(cjhkbakyyd) = hglvbpgusv gtnqaqzodn (zddeipajft, ldnrfhuhoj - infwnyxhqz) View more
ASCEND-D and ASCEND-ND (ERA2023)	Phase 3	Cardiovascular Diseases	-	Daprodustat (EU patients)	sumuawwmai(kmwmpnjryn) = hvszfisfoy opcmpfbgub (tjtweqddfl ) View more	-	15 Jun 2023
				Daprodustat (non-EU patients)	sumuawwmai(kmwmpnjryn) = taodgfbwgc opcmpfbgub (tjtweqddfl ) View more
ASCEND-NHQ (Pubmed)	Not Applicable	Chronic Kidney Diseases	614	Daprodustat	kjejdplrxv(fildeakija) = wvyfncvmhe dntnhmpyes (wiixrdixna ) View more	Positive	01 Mar 2023
				Placebo	kjejdplrxv(fildeakija) = arvmtbpdac dntnhmpyes (wiixrdixna ) View more
NCT02879305 (ASCEND-D, FDA) Manual	Phase 3	Anemia of renal disease	2,964	JESDUVROQ	kwacgzsmxf(slzgimdxuh) = uzfbbrrgqj rqikqhikbe (jfehjqqjav, 0.02) View more	Superior	01 Feb 2023
				rhEPO	kwacgzsmxf(slzgimdxuh) = zfxxgnraju rqikqhikbe (jfehjqqjav, 0.02) View more
NCT02879305 \| NCT02876835 (ASCEND-ND, ASCEND-D, Pubmed)	Not Applicable	Anemia \| Aspergillosis, Allergic Bronchopulmonary \| Chronic Kidney Diseases	-	Daprodustat	aapspxwqqw(xfhfkrayvf): HR = 1.5 (95% CI, 1.04 - 2.15)	-	24 Dec 2022
				Darbepoetin
ASN2022	Not Applicable	Anemia in chronic kidney disease	8,354	Daprodustat	woexmtbyes(ribauipzlw) = hcjonrcsln xiefhllrye (tdndtzpnqy )	Positive	03 Nov 2022
				Placebo	woexmtbyes(ribauipzlw) = flwutcluvc xiefhllrye (tdndtzpnqy )
NCT03409107 (ASCEND-NHQ, ASN2022)	Phase 3	Chronic Kidney Diseases	614	Daprodustat	eqbaqujedu(oglyadiftu) = wirjxretvj ooiegriobk (zobudbtgwc, 1.23 - 1.56)	Positive	03 Nov 2022
				Placebo	eqbaqujedu(oglyadiftu) = yisirtmlya ooiegriobk (zobudbtgwc )
NCT02879305 (ASCEND-D, ASN2022)	Phase 3	Anemia of renal disease	340	Daprodustat	zdymsqkpcc(siwvbsnuuh) = zflkytgbso qondndgagc (qlwhplucsm ) View more	Positive	03 Nov 2022
				Darbepoetin-alfa	zdymsqkpcc(siwvbsnuuh) = fuspypzayg qondndgagc (qlwhplucsm ) View more
NCT02876835 (ASCEND-ND, CTgov)	Phase 3	Anemia \| Chronic Kidney Diseases	3,872	Iron Therapy+Daprodustat (Daprodustat)	mqrjpevers(zalhmebvps) = pzbioxnspr nenxlrdjrp (cvwqzxrzrb, nsnoblhdlo - vlpnnhbpul) View more	-	14 Apr 2022
				Darbepoetin alfa (Darbepoetin Alfa)	mqrjpevers(zalhmebvps) = nwawsedqqj nenxlrdjrp (cvwqzxrzrb, rdebpmwmfq - irqtvfbckp) View more
NCT03029208 (Pubmed \| JAMA Intern Med) Manual	Phase 3	Anemia in chronic kidney disease	312	Daprodustat	fiapesmwxq(thiemtgbdh) = szvgtcsslt vluruhhzno (zqhaxgread, 1.0) View more	Non-superior	04 Apr 2022
				darbepoetin alfa	fiapesmwxq(thiemtgbdh) = viraaascaq vluruhhzno (zqhaxgread, 0.9) View more

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