A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis

The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.

Start Date20 Nov 2018

Sponsor / Collaborator

Tricida, Inc.

NCT03390842 / CompletedPhase 3

A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis

This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.

Start Date20 Dec 2017

Sponsor / Collaborator

Tricida, Inc.

NCT03317444 / CompletedPhase 3

A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis

This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily.
The maximum study duration is anticipated to be up to 16 weeks.

Start Date26 Sep 2017

Sponsor / Collaborator

Tricida, Inc.

100 Clinical Results associated with Veverimer

100 Translational Medicine associated with Veverimer

100 Patents (Medical) associated with Veverimer

Literatures (Medical) associated with Veverimer

01 May 2024·Current opinion in nephrology and hypertension

A basic solution for a complex problem: does treatment of metabolic acidosis slow CKD progression?

Review

Author: Arora, Nayan ; Freidin, Natalie ; Bodker, Kevin

Purpose of this review:

Metabolic acidosis is frequently encountered in patients with chronic kidney disease (CKD), with increasing prevalence as kidney function worsens. Treating electrolyte disturbances is the sine qua non of Nephrologists, and alkali therapy to normalize serum bicarbonate levels and slow progression of kidney disease has been embedded in clinical practice guidelines for decades on the basis of animal models and controversial clinical trials. This review will critically appraise the literature base for this recommendation and determine whether the available evidence supports this common practice, which is a timely endeavor considering the impending demotion of metabolic acidosis treatment from recommendation to practice point in forthcoming KDIGO guidelines.

Recent findings:

Earlier, open-label, studies supporting the utility of sodium bicarbonate therapy to slow progression of chronic kidney disease have been challenged by more recent, blinded, studies failing to show benefit on CKD progression. This was further demonstrated in the absence of concomitant sodium administration with the hydrochloric acid binder veverimer, which failed to demonstrate benefit on renal death, end stage kidney disease or 40% reduction in estimated glomerular filtration rate in a large multicenter trial.

Summary:

The current body of literature does not support the routine treatment of metabolic acidosis in patients with CKD and the authors agree with the forthcoming KDIGO guidelines to de-emphasize this common practice.

01 Mar 2024·Journal of the American Society of Nephrology : JASN

VALOR-CKD: A Multicenter, Randomized, Double-Blind Placebo-Controlled Trial Evaluating Veverimer in Slowing Progression of CKD in Patients with Metabolic Acidosis

Article

Author: Wheeler, David C ; Perkovic, Vlado ; Wesson, Donald E ; Bushinsky, David A ; Stasiv, Yuri ; Parsell, Dawn ; Li, Elizabeth ; Mathur, Vandana S ; Tangri, Navdeep ; Inker, Lesley A ; Walker, Michael ; Klaerner, Gerrit

Significance Statement:

Metabolic acidosis is a common complication of CKD and is associated with more rapid decline of kidney function, but well-powered controlled randomized trials testing the effect of treating metabolic acidosis on slowing CKD progression have not been conducted. The VALOR-CKD study randomized 1480 individuals with CKD and metabolic acidosis, across 320 sites to placebo or veverimer (a novel hydrochloric acid binder). The findings did not demonstrate the efficacy of veverimer in slowing CKD progression, but the difference in serum bicarbonate between placebo and drug arms was only approximately 1 mEq/L. Veverimer was safe and well tolerated.

Background:

Metabolic acidosis is common in CKD, but whether its treatment slows CKD progression is unknown. Veverimer, a novel hydrochloric acid binder that removes acid from the gastrointestinal tract, leads to an increase in serum bicarbonate.

Methods:

In a phase 3, double-blind, placebo-controlled trial, patients with CKD (eGFR of 20–40 ml/min per 1.73 m2) and metabolic acidosis (serum bicarbonate of 12–20 mEq/L) from 35 countries were randomized to veverimer or placebo. The primary outcome was the composite end point of CKD progression, defined as the development of ESKD (kidney transplantation or maintenance dialysis), a sustained decline in eGFR of ≥40% from baseline, or death due to kidney failure.

Results:

The mean (±SD) baseline eGFR was 29.2±6.3 ml/min per 1.73 m2, and serum bicarbonate was 17.5±1.4 mEq/L; this increased to 23.4±2.0 mEq/L after the active treatment run-in. After randomized withdrawal, the mean serum bicarbonate was 22.0±3.0 mEq/L and 20.9±3.3 mEq/L in the veverimer and placebo groups at month 3, and this approximately 1 mEq/L difference remained stable for the first 24 months. A primary end point event occurred in 149/741 and 148/739 patients in the veverimer and placebo groups, respectively (hazard ratio, 0.99; 95% confidence interval, 0.8 to 1.2; P = 0.90). Serious and overall adverse event incidence did not differ between the groups.

Conclusions:

Among patients with CKD and metabolic acidosis, treatment with veverimer did not slow CKD progression. The lower than expected bicarbonate separation may have hindered the ability to test the hypothesis.

Clinical Trial registry name and registration number:

VALOR-CKD, NCT03710291.

01 Dec 2023·Journal of cachexia, sarcopenia and muscle

Effects of correcting metabolic acidosis on muscle mass and functionality in chronic kidney disease: a systematic review and meta‐analysis

Review

Author: Hoorn, Ewout J. ; Visser, Wesley J. ; van der Burgh, Anna C. ; de Roos, Nicole M. ; Severs, David ; van de Braak, Elma E.M. ; van der Hoef, Iris ; de Mik ‐ van Egmond, Anneke M.E. ; Olieman, Joanne F. ; Jans, Inez

Abstract:

Metabolic acidosis unfavourably influences the nutritional status of patients with non‐dialysis dependent chronic kidney disease (CKD) including the loss of muscle mass and functionality, but the benefits of correction are uncertain. We investigated the effects of correcting metabolic acidosis on nutritional status in patients with CKD in a systematic review and meta‐analysis. A search was conducted in MEDLINE and the Cochrane Library from inception to June 2023. Study selection, bias assessment, and data extraction were independently performed by two reviewers. The Cochrane risk of bias tool was used to assess the quality of individual studies. We applied random effects meta‐analysis to obtain pooled standardized mean difference (SMD) and 95% confidence intervals (CIs). We retrieved data from 12 intervention studies including 1995 patients, with a mean age of 63.7 ± 11.7 years, a mean estimated glomerular filtration rate of 29.8 ± 8.8 mL/min per 1.73 m2, and 58% were male. Eleven studies performed an intervention with oral sodium bicarbonate compared with either placebo or with standard care and one study compared veverimer, an oral HCl‐binding polymer, with placebo. The mean change in serum bicarbonate was +3.6 mEq/L in the intervention group and +0.4 mEq/L in the control group. Correcting metabolic acidosis significantly improved muscle mass assessed by mid‐arm muscle circumference (SMD 0.35 [95% CI 0.16 to 0.54], P < 0.001) and functionality assessed with the sit‐to‐stand test (SMD −0.31 [95% CI −0.52 to 0.11], P = 0.003). We found no statistically significant effects on dietary protein intake, handgrip strength, serum albumin and prealbumin concentrations, and blood urea nitrogen. Correcting metabolic acidosis in patients with CKD improves muscle mass and physical function. Correction of metabolic acidosis should be considered as part of the nutritional care for patients with CKD.

News (Medical) associated with Veverimer

09 Oct 2024

·www.prnewswire.com

Renibus Therapeutics Announces Oral Presentation on RBT-1 at the 38th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting

- Renibus is actively enrolling a Phase 3 pivotal trial to reduce the risk of post-operative complications and improve outcomes following cardiac surgery - SOUTHLAKE, Texas, Oct. 9, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardiac, renal, and metabolic diseases, today announced that an oral presentation will be delivered on RBT-1 at the 38th EACTS Annual Meeting, taking place October 9-12, 2024, in Lisbon, Portugal. Charles Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery and Vice Chairman of Quality and Patient Safety, New York-Presbyterian Hospital, Weill Cornell Medicine, will be presenting on behalf of Renibus. RBT-1 is a single-dose, preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing non-emergent cardiac and/or valve surgery. Renibus is actively enrolling a Phase 3 pivotal trial of RBT-1 to reduce the risk of post-operative complications and improve outcomes following cardiac surgery. RBT-1 has received Breakthrough and Fast Track Designations from the US FDA. "We are thrilled that EACTS has recognized RBT-1 with an oral presentation to share our promising results with the global cardiothoracic surgery community," stated Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus. "Enrollment in the RBT-1 Phase 3 PROTECT study is ahead of schedule, and we remain on track to report top-line data in the second quarter of 2025." "RBT-1 has shown great potential in our Phase 2, multi-center, randomized, double-blind, placebo-controlled study," said Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine. "I am excited to present new data from a post-hoc analysis, which included all patients regardless of surgery delay, showing that the improvement in clinical outcomes in response to RBT-1 treatment was maintained." Details of the oral presentation at EACTS Annual Meeting: Title: Effect of RBT-1 on Clinical Outcomes the Safety Population of a Phase 2 Study in Cardiac Surgery Date and Time: Friday, October 11, 2024, 9:15 am Presenting Author: Charles Mack, MD Authors: C. Mack (New York, USA), M. Jessen (Dallas, USA), A. Shaw (Cleveland, USA), S. Ruiz (Southlake, USA), C. Wang (Piscataway, USA), S. Snapinn (Seattle, USA), B. Singh (Southlake, USA), A. Lamy (Ontario, Canada) About RBT-1 RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory and antioxidant pathways currently in Phase 3 [NCT # 06021457] for its lead indication to reduce post-operative complications following cardiothoracic surgery. Renibus completed the Phase 2 study of RBT-1 (NCT04564833) in February 2023 and announced positive final results from this study in May 2023. In October 2023, Renibus initiated enrollment and administration of RBT-1 in its PROTECT Phase 3 pivotal study. RBT-1 was granted Breakthrough Therapy designation status from the U.S. FDA to reduce the risk of complications in patients undergoing cardiothoracic surgery. About Renibus Therapeutics Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus' first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations. Veverimer is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in clinical trials. Renibus has three additional assets at earlier stages of development. For more information, please visit the Company's website at and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-914-1962 Business Development Contact Jamie Donadio CFO, Renibus [email protected] SOURCE Renibus Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 3Fast TrackBreakthrough Therapy

24 Sep 2024

·www.prnewswire.com

Renibus Therapeutics Announces Participation at Upcoming Investor Conferences

SOUTHLAKE, Texas, Sept. 24, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio, renal and metabolic diseases, today announced participation in the following upcoming investor conferences: Oppenheimer Private Life Sciences Company Showcase, October 1, 2024, New York, NY 4th Annual Needham Private Biotech Company Virtual 1x1 Forum, October 8-9, 2024 Renibus management will be available to meet with investors one-on-one during these events. About Renibus Therapeutics Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus' first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations. Veverimer is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in clinical trials. Renibus has three additional assets at earlier stages of development. For more information, please visit the Company's website at and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-914-1962 Business Development Contact Jamie Donadio CFO, Renibus [email protected] SOURCE Renibus Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Fast TrackAcquisition

26 Apr 2024

·www.prnewswire.com

Renibus Therapeutics Announces Oral Presentations on RBT-1 at AATS and SCA Medical Conferences

SOUTHLAKE, Texas, April 26, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio, renal and metabolic diseases, today announced its participation at two prestigious medical conferences: the American Association for Thoracic Surgery (AATS) 104th Annual Meeting and the Society of Cardiovascular Anesthesiologists (SCA) 46th Annual Meeting, both taking place in Toronto, Canada, April 27-30, 2024. "We are pleased to present additional clinical data on RBT-1 at the AATS and SCA meetings in collaboration with key opinion leaders in our field, Drs. Charles Mack and Andrew Shaw," stated Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus. "These presentations are critical to advancing the understanding of our preconditioning approach with RBT-1, and we thank the meeting organizers and principal investigators for their partnership. Our Phase 3 PROTECT study is enrolling well and we remain on track to report top-line data in the third quarter of 2025." RBT-1 (stannic protoporfin / iron sucrose) is a single dose, multi-organ, preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing cardiac surgery.Renibus Therapeutics is actively enrolling its PROTECT Phase 3 pivotal trial evaluating RBT-1's potential to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. RBT-1 has received both FDA Breakthrough and Fast Track Designations. Details of the oral presentations at AATS: Title: RBT-1 Reduces Incidence of Blood Product Utilization in Patients Undergoing Non-Emergent Coronary Artery Bypass Grafting and/or Valve Surgery Date and Time: Sunday, April 28th at 9:44 am ET Location: Room 714 Presenter: Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine Title: RBT-1 Reduces the Number of Post-Operative Complications Associated with Cardiac Surgery Date and Time: Sunday, April 28th at 4:03 pm ET Location: Theater 2, Exhibit Hall Presenter: Bhupinder Singh, MD, Chief Medical Officer, Renibus Details of the oral presentation at SCA: Title: RBT-1 Improves Clinical Outcomes in Patients Requiring Prolonged Intensive Care Unit Stay Following Non-Emergent Cardiac Surgery Date and Time: Sunday, April 28th at 3:00 pm ET Session: Best of Meeting Oral Presenter: Andrew Shaw, MD, FRCA, FCCM, FFICM, Professor and Chair, Department of Intensive Care and Resuscitation, Cleveland Clinic About RBT-1 RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory andantioxidant pathways currently in Phase 3 [NCT # 06021457] for its lead indication to reduce post-operative complications following cardiothoracic surgery. Renibus completed the Phase 2 study of RBT-1 (NCT04564833) in February 2023 and announced positive final results from this study in May 2023. In October 2023, Renibus initiated enrollment and administration of RBT-1 in its PROTECT Phase 3 pivotal study. RBT-1 was granted Breakthrough Therapy designation status from the U.S. FDA to reduce the risk of complications in patients undergoing cardiothoracic surgery. About Renibus Therapeutics Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus' first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations. Veverimer is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in clinical trials. Renibus has three additional assets at earlier stages of development. For more information, please visit the Company's website at and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-914-1962 Business Development Contact Jamie Donadio CFO, Renibus [email protected] SOURCE Renibus Therapeutics

Phase 3Fast TrackPhase 2Breakthrough Therapy

100 Deals associated with Veverimer

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Indication	Highest Phase	Country/Location	Organization	Date
Acidosis	NDA/BLA	US	Tricida, Inc.	04 Sep 2019
Chronic Kidney Diseases	Phase 3	US	Tricida, Inc.	26 Sep 2017
Chronic Kidney Diseases	Phase 3	BG	Tricida, Inc.	26 Sep 2017
Chronic Kidney Diseases	Phase 3	HR	Tricida, Inc.	26 Sep 2017
Chronic Kidney Diseases	Phase 3	GE	Tricida, Inc.	26 Sep 2017
Chronic Kidney Diseases	Phase 3	HU	Tricida, Inc.	26 Sep 2017
Chronic Kidney Diseases	Phase 3	RS	Tricida, Inc.	26 Sep 2017
Chronic Kidney Diseases	Phase 3	SI	Tricida, Inc.	26 Sep 2017
Chronic Kidney Diseases	Phase 3	UA	Tricida, Inc.	26 Sep 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03390842 (Pubmed) Manual	Phase 3	Acidosis \| Chronic Kidney Diseases	77	Veverimer	tzshaawlwv(mtcnbomxba): P-Value = 0.0002 View more	Positive	25 Feb 2022
				Placebo
NCT03390842 (CTgov)	Phase 3	Chronic Kidney Diseases	196	TRC101 (TRC101 Treatment Arm)	psuurigtge(sirtwxmzmg) = bsdxvwxwmw cddyktofbz (tbvxvnyzca, pbdcnyfphq - orkiuuzpnr) View more	-	22 Oct 2021
				Placebo (Placebo Treatment Arm)	psuurigtge(sirtwxmzmg) = acctrzimwz cddyktofbz (tbvxvnyzca, tytversmzj - lxqtenbbtz) View more
NCT03317444 (CTgov)	Phase 3	Chronic Kidney Diseases	217	TRC101 (TRC101 Treatment Arm)	kdmrymjlum(hfukdvothq) = xlbruqkxyz qvkfxsrdwu (ubewspwmhv, jtysvpoucr - fjatedfmgk) View more	-	26 Apr 2021
				Placebo (Placebo Treatment Arm)	kdmrymjlum(hfukdvothq) = djoaquckei qvkfxsrdwu (ubewspwmhv, zdkjuzikif - bcezfqcpqi) View more
ASN2020	Phase 3	Chronic Kidney Diseases	217	Veverimer	cyievdtfdr(dgmuynncut) = tgllabgdjy dqvqqscutk (ufgvqemwvl )	Positive	19 Oct 2020
TRCA-301E (ASN2020)	Phase 3	Diabetes Mellitus \| Chronic Kidney Diseases	196	Veverimer	fygxbovowx(xywybjoozu) = significantly improved in the veverimer group (+12.5 v +0.3, P <0.001) fokmfibpgv (znsqrtmwip )	Positive	19 Oct 2020
ASN2020	Phase 3	Acidosis \| Chronic Kidney Diseases	193	Veverimer	tijtmdzkvw(zkmkvzfnef) = kfehmsxwlf eeknwaxest (hbpuxxfwls )	Positive	19 Oct 2020
ASN2020	Phase 3	-	217	Veverimer	vkskinygon(ejvpchdwrt) = improved both KDQOL-PFD scores and RCS time umujxsqvte (qjkvdwrpyr ) View more	Positive	19 Oct 2020
ASN2020	Not Applicable	-	-	Veverimer	kelihnbkkc(nynseyvsdi) = qzqniohebj ejlhzazewu (sulwbsuidc )	Positive	19 Oct 2020
ASN2020	Phase 1	-	46	Veverimer	xeixsletng(pxtpezxdek) = mxbetymkgu ibdirsdbao (zvuyoacarw )	Positive	19 Oct 2020
				Omeprazole	xeixsletng(pxtpezxdek) = qjkxymelwt ibdirsdbao (zvuyoacarw )
TRCA-301E (ERA2020)	Phase 3	Chronic Kidney Diseases	196	Veverimer	fqvsvsmlrn(yvkgfunuyo) = isxrftytwv jqpfhgzjwc (jhakpawetk ) View more	Positive	06 Jun 2020
				Placebo	fqvsvsmlrn(yvkgfunuyo) = fawbvvjahx jqpfhgzjwc (jhakpawetk )

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