A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Veverimer in Adults With CKD and Metabolic Acidosis (The REVIVE Study)

The purpose of this 26 week study is is to evaluate the efficacy and safety of veverimer in treating adults with moderate-to-severe chronic kidney disease (CKD) and metabolic acidosis.

Start Date15 Jan 2026

Sponsor / Collaborator

Renibus Therapeutics, Inc.

NCT03710291

/ TerminatedPhase 3

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.

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 2025·Kidney360

Veverimer, a Nonabsorbed Gastrointestinal Tract HCl Binder, Decreases Renal Ammoniagenesis and Mitigates Nephrotoxic Serum Nephritis

Article

Author: Johnson, Ali C.M. ; Zager, Richard A.

Key Points:

Veverimer, a nonabsorbed gastrointestinal tract HCl binder, increases bicarbonate generation, causes bicarbonaturia, and thus decreases renal ammoniagenesis.Decreases in ammoniagenesis can suppress kidney disease–induced alternative complement pathway activation.As a result of the above changes, decreases in renal injury, as induced by nephrotoxic serum injection, can occur.

Background:

Increased tubular ammoniagenesis is an adaptive response to progressive kidney disease, facilitating net acid excretion. However, excess ammonia production can also exacerbate kidney disease progression, in part, by activating the alternative complement cascade. Oral Na bicarbonate therapy can decrease the systemic H+ burden, limiting ammonia production. However, poor compliance limits bicarbonate's efficacy. Veverimer is an oral, Na+-free, nonabsorbed polymer that binds H+ within the gastrointestinal (GI) tract. This stimulates GI carbonic anhydrase-mediated bicarbonate production and systemic bicarbonate uptake. Hence, the goals of this study were to test whether GI HCl binding decreases renal tubular ammoniagenesis, to assess whether complement activation decreases, and to determine whether these changes can mitigate nephrotoxic serum (NTS) nephritis, in which complement activation may play a role.

Methods:

A normal diet± veverimer (4.5% w/w) was fed to normal mice for approximately 1 week. Veverimer's effect on plasma bicarbonate; blood/urinary pH; urinary ammonia excretion; and tubular H+ transporter, NHE3, density was assessed. Additional mice were fed the normal or veverimer diet after NTS injection. Urine protein, albumin, ammonia, C5b-9 excretion, and plasma C3a levels were measured 1 week and/or 2 weeks after NTS injection. Renal histologic changes (hematoxylin and eosin stain; C5b-9, CD45 immunohistochemistry), and selected injury mediators/biomarkers (NGAL, IL-6, MCP-1, TGFβ1, and endothelin-1 mRNAs) were also assessed.

Results:

Veverimer increased plasma bicarbonate/urinary pH, reduced urinary ammonia, and decreased NHE3 in normal mice. Veverimer also reduced NTS-induced proteinuria/albuminuria, urinary ammonia, and C5b-9 excretion (by approximately 60%, 75%, and 50%, respectively). Significant reductions in NTS-induced glomerular/tubulointerstitial injury, inflammatory/profibrotic gene expression, renal C5b-9 deposition, and suppressed plasma C3a levels were observed. Oral bicarbonate also conferred protection, implicating bicarbonate's role in veverimer's beneficial effect.

Conclusions:

Veverimer-mediated bicarbonate generation can suppress renal ammoniagenesis and complement activation. These findings suggest a potential benefit of veverimer/bicarbonate therapy in selected complement-mediated kidney diseases.

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

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.

News (Medical) associated with Veverimer

10 Jun 2025

·www.prnewswire.com

Renibus Therapeutics Announces FDA Orphan Drug Designation for Veverimer for the Treatment of Anti-glomerular Basement Membrane Disease (anti-GBM)

SOUTHLAKE, Texas, June 10, 2025 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to veverimer for the treatment of anti-glomerular basement membrane disease (anti-GBM), an ultra-rare life-threatening condition characterized by acute renal failure associated with the presence of auto-immune antibodies with affinity for the glomerular basement membrane. "Ultra-rare life-threatening conditions, including anti-GBM and several other forms of glomerular and tubulointerstitial kidney diseases, can be aggressive and challenging to treat effectively with current therapies," said Bhupinder Singh M.D., Chief Medical Officer of Renibus. "This Orphan Drug Designation further underscores the potential of veverimer to offer a significant advantage beyond drugs currently used to treat kidney disease, and we look forward to advancing this asset in the clinic." The Orphan Drug Designation program is intended to encourage the development of products for diseases that affect fewer than 200,000 individuals in the United States. With this designation Renibus is eligible for certain incentives, such as tax credits for clinical trials, exemption from user fees, and a potential 7 years of market exclusivity upon approval. Richard Zager, Senior Vice President of Translational Research of Renibus, commented, "Veverimer markedly suppresses ammoniagenisis and associated activation of the complement cascade, which are key mediators of anti-GBM disease and other complement mediated renal diseases. We are continuing to evaluate the potential of veverimer to address these diseases of high unmet medical need." 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' lead first-in class combination drug therapy 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. RBT-1 has just completed enrollment in a Phase 3 pivotal trial (called PROTECT) measuring its primary objective to reduce the risk of post operative complications and improve outcomes following cardiac surgery. The drug has been granted FDA Breakthrough and Fast Track Designations by the Division of Cardiology and Nephrology at the FDA. Veverimer is an oral, non-absorbed hydrochloric acid binder that has been granted Orphan Drug Designation for the treatment of anti-glomerular basement membrane disease. Renibus is also evaluating veverimer's potential use for the treatment of other renal diseases. 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

Orphan DrugFast TrackPhase 3

25 Apr 2025

·www.prnewswire.com

Renibus Therapeutics Announces Poster Presentation on RBT-1 at the 47th Annual Meeting of the Society of Cardiovascular Anesthesiologists (SCA)

- Renibus recently completed enrollment in a Phase 3 pivotal trial PROTECT to reduce the risk of post-operative complications and improve outcomes following cardiac surgery - SOUTHLAKE, Texas, April 25, 2025 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardiac, renal, and metabolic diseases, today announced that a poster presentation will be delivered on RBT-1 at the 47th Annual Meeting of the Society of Cardiovascular Anesthesiologists (SCA), taking place April 26-29, 2025 in Montreal. RBT-1 is a single-dose, first-in-class, preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing non-emergent cardiac and/or valve surgery. Renibus previously completed a Phase 2 study of RBT-1 (NCT04564833) in February 2023, announced positive final results from this study in May 2023, and has recently completed enrollment in its Phase 3 PROTECT study. RBT-1 has received Breakthrough and Fast Track Designations from the US FDA. "We are excited to build on our recent momentum of achieving full enrollment in our Phase 3 PROTECT study with a poster presentation at SCA 2025 that we can share with the global anesthesiologist community," stated Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus. "Our poster highlights the complicated economic impact of post-operative complications and increasing costs for CABG and value surgery to the healthcare system, which directly affects anesthesiologists. With the use of RBT-1 in our Phase 2 study, we reduced the complication rates from cardiovascular surgery, and in turn, the overall healthcare costs. We look forward to continuing to demonstrate these encouraging results in Phase 3." Frans van Wagenberg, MD, Huntsville Heart Center, Huntsville, Alabama, commented, "I am pleased to present results of a cost-analysis based on a Phase 2 trial which suggest that RBT-1 has a protective effect, leading to lower complication rates and reduced average expected costs overall. Additional data from an ongoing Phase 3 trial, which includes a 1-year post-discharge follow-up, will further evaluate the impact of RBT-1 on clinical, economic, and qualitative outcomes compared to standard care." Details of the poster presentation at SCA 2025: Title: "Clinical and Economic Impact of RBT-1 on Post-operative Complications and Costs for CABG and Valve Surgery" Date and Time: Sunday, April 27, 2025 at 12:30 Authors: Frans van Wagenberg, MD, Lynn Cherry, PhD, Bhupinder Singh, MD, Stacey Ruiz, PhDc, Raf Magar MB About RBT-1 RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory andantioxidant pathways currently being evaluated in the Phase 3 PROTECT study for its lead indication to reduce post-operative complications following cardiothoracic surgery. Previously, 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 and announced completion of enrollment in April 2025. 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 (called PROTECT) 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. The drug has received FDA Orphan Drug Designation. 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 TrackPhase 2Orphan DrugBreakthrough Therapy

26 Mar 2025

·www.prnewswire.com

Renibus to Participate in the 24th Annual Needham Healthcare Virtual Healthcare Conference

SOUTHLAKE, Texas, March 26, 2025 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardiac, renal, and metabolic diseases, today announced its participation in the 24th Annual Needham Virtual Healthcare Conference taking place April 7-10, 2025. This event is being held in a virtual format during which Company management will participate in one-on-one meetings with investors. 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 Track

100 Deals associated with Veverimer

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Acidosis	NDA/BLA	United States	Tricida, Inc.	04 Sep 2019
Chronic Kidney Diseases	Phase 3	United States	Tricida, Inc.	20 Dec 2017
Chronic Kidney Diseases	Phase 3	Bulgaria	Tricida, Inc.	20 Dec 2017
Chronic Kidney Diseases	Phase 3	Hungary	Tricida, Inc.	20 Dec 2017
Chronic Kidney Diseases	Phase 3	Serbia	Tricida, Inc.	20 Dec 2017
Chronic Kidney Diseases	Phase 3	Slovenia	Tricida, Inc.	20 Dec 2017
Chronic Kidney Diseases	Phase 3	Ukraine	Tricida, Inc.	20 Dec 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03710291 (VALOR-CKD, Pubmed \| NEWS 1 \| NEWS 2)	-	-	1,480	Veverimer	dtkdfsryfj(mjjsvwrrtb) = rldpmywtpj amccducgsh (jsjdlvekql )	Negative	24 Oct 2022
				安慰剂	dtkdfsryfj(mjjsvwrrtb) = wavixrgzcn amccducgsh (jsjdlvekql )
NCT03390842 (Pubmed) Manual	Phase 3	Acidosis \| Chronic Kidney Diseases	77	Veverimer	hxmoiqetiy(krhgufakfw): P-Value = 0.0002 View more	Positive	25 Feb 2022
				Placebo
NCT03390842 (CTgov)	Phase 3	Acidosis \| Chronic Kidney Diseases	196	TRC101 (TRC101 Treatment Arm)	qwfcmiizhv = anrshltzxh kfjjcglmvr (sowlblhpjb, manizlqual - jeklaoojfg) View more	-	22 Oct 2021
				Placebo (Placebo Treatment Arm)	qwfcmiizhv = eemgzvugit kfjjcglmvr (sowlblhpjb, zocfkcclbu - ituzbfincm) View more
NCT03317444 (CTgov)	Phase 3	Acidosis	217	TRC101 (TRC101 Treatment Arm)	obzyugvvbd = dpdcxqqtxy egdauknslb (jxvbwhgweu, ewpucvxahf - cpqwccexyv) View more	-	26 Apr 2021
				Placebo (Placebo Treatment Arm)	obzyugvvbd = sagwqvyopc egdauknslb (jxvbwhgweu, wrzhzqyuid - lkcqctroes) View more
ASN2020	Phase 3	Acidosis \| Chronic Kidney Diseases	193	Veverimer	ngihoscstb(wffaiqagqe) = bxlgfjaptu kesroglvbd (jcdvebsybx )	Positive	19 Oct 2020
Phase 3 randomized, blinded, placebo-controlled trials (ASN2020)	Phase 3	Chronic Kidney Diseases	217	Veverimer	khmchfegbl(gqscphloos) = vjgzfndpqj axuorloeco (eoawjokdto )	Positive	19 Oct 2020
ASN2020	Phase 3	Diabetes Mellitus \| Chronic Kidney Diseases	196	Veverimer	czvnomxpln(pxcunodnlz) = significantly improved in the veverimer group (+12.5 v +0.3, P <0.001) zupsrxxbjy (auedrozrfs )	Positive	19 Oct 2020
ASN2020	Phase 3	-	217	Veverimer	hffyijjviw(nqhkvutbia) = improved both KDQOL-PFD scores and RCS time jsqemuknra (qiwehsduhs ) View more	Positive	19 Oct 2020
ASN2020	Phase 1	-	46	Veverimer	auuyrpkarj(mxotimfkzd) = ylncwmahnx eyrkazcdnd (rdmrcsuzzf )	Positive	19 Oct 2020
				Omeprazole	auuyrpkarj(mxotimfkzd) = hxajzfgztc eyrkazcdnd (rdmrcsuzzf )
ERA2020	Phase 3	Chronic Kidney Diseases	196	Veverimer	hetfiswdcx(ojgmwvecin) = ogjdicfmgi ydswhfoifl (lgsmnaqoms ) View more	Positive	06 Jun 2020
				Placebo	hetfiswdcx(ojgmwvecin) = dodzfwtlpm ydswhfoifl (lgsmnaqoms )

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