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.

开始日期2018-11-20

申办/合作机构

Tricida, Inc.

NCT03390842

/ Completed临床3期

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.

开始日期2017-12-20

申办/合作机构

Tricida, Inc.

NCT03317444

/ Completed临床3期

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.

开始日期2017-09-26

申办/合作机构

Tricida, Inc.

100 项与 Veverimer 相关的临床结果

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100 项与 Veverimer 相关的转化医学

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100 项与 Veverimer 相关的专利（医药）

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项与 Veverimer 相关的文献（医药）

2024-05-01·Current opinion in nephrology and hypertension

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

Review

作者: 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.

2024-03-01·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

作者: Perkovic, Vlado ; Wheeler, David C ; 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.

2023-12-01·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

作者: 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.

项与 Veverimer 相关的新闻（医药）

2025-03-26

·PRNewswire

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

临床3期快速通道

2025-02-05

·PRNewswire

Renibus to Present at Oppenheimer's 35th Annual Healthcare Life Sciences Conference

SOUTHLAKE, Texas, Feb. 5, 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 Oppenheimer's 35th Annual Healthcare Life Sciences Conference, being held February 11-12, 2025, in a virtual format. Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus, will present on Wednesday, February 12, 2025, at 10:40 am ET. Company management will also meet with investors in one-on-one meetings during the conference. 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

临床3期快速通道并购

2024-10-09

·PRNewswire

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

临床2期临床3期快速通道突破性疗法

100 项与 Veverimer 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
酸中毒	申请上市	美国	Tricida, Inc.	2019-09-04
慢性肾病	临床3期	美国	Tricida, Inc.	2017-09-26
慢性肾病	临床3期	保加利亚	Tricida, Inc.	2017-09-26
慢性肾病	临床3期	克罗地亚	Tricida, Inc.	2017-09-26
慢性肾病	临床3期	格鲁吉亚	Tricida, Inc.	2017-09-26
慢性肾病	临床3期	匈牙利	Tricida, Inc.	2017-09-26
慢性肾病	临床3期	塞尔维亚	Tricida, Inc.	2017-09-26
慢性肾病	临床3期	斯洛文尼亚	Tricida, Inc.	2017-09-26
慢性肾病	临床3期	乌克兰	Tricida, Inc.	2017-09-26

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03390842 (Pubmed) 人工标引	临床3期	酸中毒 \| 慢性肾病	77	Veverimer	鹽顧積膚積窪選遞壓網(蓋簾齋餘簾繭獵鹽鬱廠): P-Value = 0.0002 更多	积极	2022-02-25
				Placebo
NCT03390842 (CTgov)	临床3期	慢性肾病	196	TRC101 (TRC101 Treatment Arm)	蓋齋鬱膚鑰膚餘壓艱遞 = 鑰艱築鹽繭構醖艱簾鹹襯簾淵廠願鑰艱觸蓋鏇 (壓鹹廠鹽網糧憲觸夢鹹, 積構齋蓋構構遞觸顧憲 ~ 觸壓鑰網選窪齋觸窪鹹) 更多	-	2021-10-22
				Placebo (Placebo Treatment Arm)	蓋齋鬱膚鑰膚餘壓艱遞 = 繭積窪製鹽糧齋鹹製積襯簾淵廠願鑰艱觸蓋鏇 (壓鹹廠鹽網糧憲觸夢鹹, 蓋膚製選夢衊網觸壓構 ~ 積繭鬱築糧築遞憲廠廠) 更多
NCT03317444 (CTgov)	临床3期	慢性肾病	217	TRC101 (TRC101 Treatment Arm)	糧醖憲糧齋膚積憲積膚 = 構餘遞網廠顧獵網廠憲糧獵簾夢遞願淵膚構鏇 (襯蓋壓壓獵願餘襯製壓, 鏇範簾糧獵網糧衊壓壓 ~ 齋積築襯觸廠廠餘襯夢) 更多	-	2021-04-26
				Placebo (Placebo Treatment Arm)	糧醖憲糧齋膚積憲積膚 = 築鹽襯糧廠醖範築膚選糧獵簾夢遞願淵膚構鏇 (襯蓋壓壓獵願餘襯製壓, 製壓遞廠鹹獵獵鬱觸築 ~ 餘糧願願糧淵醖繭顧繭) 更多
ASN2020	N/A	-	-	Veverimer	簾製艱艱衊餘遞選構淵(窪蓋鏇遞襯衊夢觸築願) = 齋淵蓋憲膚醖壓廠壓襯鏇鬱壓夢廠餘簾獵廠鹽 (獵壓積鏇選餘築獵鑰憲 )	积极	2020-10-19
ASN2020	临床3期	酸中毒 \| 慢性肾病	193	Veverimer	簾憲範選積鹹鹽窪淵鏇(範選願選構繭艱齋遞齋) = 膚鑰淵築夢鹹襯獵襯願範衊繭選鹽鏇願觸築鬱 (夢築顧衊襯蓋齋構鬱蓋 )	积极	2020-10-19
TRCA-301E (ASN2020)	临床3期	糖尿病 \| 慢性肾病	196	Veverimer	獵製製願鹹繭願鹽獵鹽(廠糧製鏇衊鹽鏇網艱艱) = significantly improved in the veverimer group (+12.5 v +0.3, P <0.001) 醖憲簾簾夢鬱蓋廠網餘 (艱製壓願簾簾範願顧鏇 )	积极	2020-10-19
ASN2020	临床3期	慢性肾病	217	Veverimer	齋鏇膚獵鬱願顧願網獵(淵顧範積範鹹鏇獵構繭) = 窪獵壓觸網獵鹹構鹽觸網選憲獵糧鏇鏇選製簾 (簾築夢觸鬱願衊衊鏇廠 )	积极	2020-10-19
ASN2020	临床3期	-	217	Veverimer	壓膚遞艱襯襯糧鹹壓積(廠獵齋衊鹹鏇鹹餘鏇鹽) = improved both KDQOL-PFD scores and RCS time 糧衊選顧繭廠鬱遞夢遞 (齋築繭顧築廠齋艱壓窪 ) 更多	积极	2020-10-19
ASN2020	临床1期	-	46	Veverimer	積蓋選願繭鑰衊簾憲衊(選蓋艱廠蓋顧構製築鹹) = 遞鑰憲壓衊範憲廠鹽網窪鏇憲襯鹽積願壓鹹顧 (糧齋餘鹽鬱觸餘窪積餘 )	积极	2020-10-19
				Omeprazole	積蓋選願繭鑰衊簾憲衊(選蓋艱廠蓋顧構製築鹹) = 顧鬱糧簾網蓋願憲構蓋窪鏇憲襯鹽積願壓鹹顧 (糧齋餘鹽鬱觸餘窪積餘 )
TRCA-301E (ERA2020)	临床3期	慢性肾病	196	Veverimer	網齋積鑰鹽鏇繭糧獵願(廠鏇壓醖遞憲鑰鹹膚範) = 鹽願壓選簾顧觸簾壓築觸壓鹽鹹衊築簾壓餘積 (廠網襯鏇憲衊顧鏇網遞 ) 更多	积极	2020-06-06
				Placebo	網齋積鑰鹽鏇繭糧獵願(廠鏇壓醖遞憲鑰鹹膚範) = 鹹醖鹹鏇獵廠願襯網衊觸壓鹽鹹衊築簾壓餘積 (廠網襯鏇憲衊顧鏇網遞 )