Renal & Urology clinical trial failures

Phase II Renal Angiomyolipomas trial by University Hospital, Bordeaux. Stop reason: OTHER/UNKNOWN.

target number of subject not reached

Early Phase I End Stage Renal Disease trial by Mayo Clinic. Stop reason: OPERATIONAL.

Unable to enroll patients for the trial.

Phase III Hyperphosphatemia Related to Chronic Kidney Disease trial by Keryx Biopharmaceuticals. Stop reason: OPERATIONAL.

Sponsor decision

Phase III Delayed Graft Function trial by Apellis Pharmaceuticals, Inc.. Stop reason: OTHER/UNKNOWN.

Study temporarily suspended due to company acquisition and ongoing strategic evaluation of the program

Phase II Membranous Nephropathy trial by Centre Hospitalier Universitaire de Nice. Stop reason: OTHER/UNKNOWN.

Only screenfail during inclusion period

Phase I Multi-Drug Resistant Nephrotic Syndrome trial by The Children's Hospital of Zhejiang University School of Medicine. Stop reason: OPERATIONAL.

no participants enrolled

Phase III Distal Renal Tubular Acidosis trial by Advicenne Pharma. Stop reason: OPERATIONAL.

COVID-19 pandemic negatively impacted the ability to enroll patients.

Phase I Chronic Kidney Disease trial by Bayer. Stop reason: OTHER/UNKNOWN.

The study is no longer required.

Phase IV End Stage Renal Disease on Dialysis trial by University of Alberta. Stop reason: OPERATIONAL.

Personnel/staffing issues.

Unknown Genitourinary Syndrome of Menopause (GSM) trial by NYU Langone Health. Stop reason: OTHER/UNKNOWN.

The study was placed on hold by the Sponsor for \~1 year. Given the prolonged hold and absence of participant activity, the study was closed.

Phase II Lower Urinary Tract Symptoms trial by Iman Al-Naggar, PhD. Stop reason: OPERATIONAL.

Recruitment not proceeding as planned.

Phase II Kidney Transplant trial by Prim. Priv. Doz. Dr. Daniel Cejka. Stop reason: OTHER/UNKNOWN.

due to organizational reason

Phase III Kidney Transplantation trial by University Hospital, Rouen. Stop reason: OTHER/UNKNOWN.

Difficulty in enrolling new patients

Phase IV Kidney Failure, Chronic trial by Centre Hospitalier Departemental Vendee. Stop reason: OPERATIONAL.

Recruitment difficulties

Phase II Secondary Hyperparathyroidism Due to Renal Causes trial by OPKO Health, Inc.. Stop reason: OPERATIONAL.

Cohort 1 completed and cohort 2 terminated prior to initiation per company decision

Phase II Acute Kidney Injury Following Cardiac Surgery trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor Decision

Phase III Interstitial Cystitis trial by Jocelyn Fitzgerald. Stop reason: OPERATIONAL.

unable to reach the recruitment numbers required to power our primary outcome

Phase III Acute Kidney Injury trial by The George Institute. Stop reason: OPERATIONAL.

The vanguard phase is complete. Further phases did not proceed due to funding constraints. A revised methodology is planned, requiring a new protocol and approvals.

Phase II Acute Kidney Injury trial by Genentech, Inc.. Stop reason: OTHER/UNKNOWN.

Unlikely to demonstrate a statistically significant clinical benefit

Phase II Kidney Transplantation trial by ITB-Med LLC. Stop reason: OPERATIONAL.

After enrolment was complete, and sufficient data was collected to fully characterize the highest dose cohort, study follow up was terminated by the sponsor for non-safety related reasons.

Phase IV Obstetric trial by University of Alabama at Birmingham. Stop reason: OPERATIONAL.

Ran out of funding

Phase IV Urinary Retention trial by Antonio Nocito, MD. Stop reason: EFFICACY/FUTILITY.

The study was terminated prematurely following a pre-planned interim analysis demonstrating futility

Phase I Membranous Nephropathy trial by Tenet Medicines. Stop reason: OTHER/UNKNOWN.

Sponsor change

Unknown Overactive Bladder Syndrome trial by University of Alabama at Birmingham. Stop reason: OPERATIONAL.

Not funded by industry

Phase III Acidosis, Renal Tubular trial by Advicenne Pharma. Stop reason: OPERATIONAL.

No patients enrolled. Study no longer required due to completion of long term safety study in the EU.

Phase II Kidney Transplantation trial by ITB-Med LLC. Stop reason: OPERATIONAL.

Sponsor decision, indication no longer under evaluation

Phase II Gout trial by Assistance Publique - Hôpitaux de Paris. Stop reason: OPERATIONAL.

Peremption of treatments, difficulty of patients recrutment (28 patients in 3 years) and lack of funding to pursue the study.

Phase II Interstitial Cystitis trial by Urigen. Stop reason: OPERATIONAL.

Prematurely terminated due to data inconsistent with the experimental plan and lack of funding

Phase II Chronic Kidney Diseases trial by Mayo Clinic. Stop reason: OPERATIONAL.

Due to lack of funding

Early Phase I Stress Urinary Incontinence trial by Northwell Health. Stop reason: OTHER/UNKNOWN.

Principal Investigator changing locations.

Unknown Disorder of Urinary Stent trial by Phoenix Children's Hospital. Stop reason: OPERATIONAL.

The study was withdrawn prior to IRB approval and prior to enrollment. The study was never opened, and no participants were enrolled.

Phase III Renal Insufficiency, Chronic trial by AstraZeneca. Stop reason: OPERATIONAL.

The study started enrollment in Sep 2021 and despite huge efforts the rate of patient enrollment continued to be below target such that the completion of the study within a reasonable timeframe was deemed very unlikely.

Phase II Congenital Adrenal Hyperplasia trial by Spruce Biosciences. Stop reason: OTHER/UNKNOWN.

The SPR001-203 clinical trial did not achieve the primary efficacy endpoint of the absolute change in daily GC dose from baseline at week 24. It was decided to terminate the SPR001-205 in response to the SPR001-203 efficacy data.

Phase III Autosomal Recessive Polycystic Kidney Disease (ARPKD) trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OTHER/UNKNOWN.

Study stopped before enrolling any participants.

Phase I Kidney Transplantation trial by University of Utah. Stop reason: OPERATIONAL.

lack of funding

Phase III Idiopathic Membranous Nephropathy trial by Peking Union Medical College Hospital. Stop reason: OPERATIONAL.

insufficient patient enrollment

Phase III IgA Nephropathy trial by Omeros Corporation. Stop reason: EFFICACY/FUTILITY.

IA did not meet the prespecified primary endpoint.

Phase II Stress Urinary Incontinence trial by Versameb AG. Stop reason: OPERATIONAL.

The study has not enrolled study participants, and will not start enrolling, due to insufficient funding and is withdrawn from .

Phase III Primary Membranous Nephropathy trial by The University of Queensland. Stop reason: OPERATIONAL.

The study was deemed unfeasible due to unforeseen financial limitations

Phase II Diabetic Kidney Disease trial by ZyVersa Therapeutics, Inc.. Stop reason: OPERATIONAL.

Withdrawn due to patient enrollment challenges

Phase I Subclinical Acute Antibody-mediated Rejection in Kidney Transplantation trial by Assistance Publique - Hôpitaux de Paris. Stop reason: OTHER/UNKNOWN.

disengagement of the sponsor Alexion Pharmaceuticals

Phase III Renal Transplant Rejection trial by University of Edinburgh. Stop reason: OPERATIONAL.

COVID

Phase IV Kidney Transplantation trial by University of Southern California. Stop reason: OTHER/UNKNOWN.

Research contract expired

Phase I Congenital Adrenal Hyperplasia trial by University of Texas Southwestern Medical Center. Stop reason: OPERATIONAL.

The study has been affected significantly by the COVID pandemic, drug supply/drug amendment, low recruitment interest, and FDA approval of another drug with the same indication, so this study has not met its primary endpoint data requirements.

Phase II Kidney Transplantation in Highly Sensitized Patients trial by Hansa Biopharma AB. Stop reason: OPERATIONAL.

Company decision, not due to any safety reason

Phase II Chronic Kidney Disease trial by Eli Lilly and Company. Stop reason: EFFICACY/FUTILITY.

Study was terminated due to a lack of foreseeable clinical benefit in the proposed chronic kidney disease population, following the termination of a related heart failure study that demonstrated no benefit in an overlapping patient group.

Phase II Congenital Adrenal Hyperplasia trial by Spruce Biosciences. Stop reason: EFFICACY/FUTILITY.

Study did not meet its primary endpoint.

Phase III Congenital Cystic Kidney Disease trial by Sanofi. Stop reason: EFFICACY/FUTILITY.

LTS15823 (long-term extension of the EFC15392 study) was stopped after protocol specified interim analysis for futility of the parent EFC15392 study met the prespecified stopping rule based on the primary outcome measure.

Phase III Urinary Bladder Neoplasms trial by Bristol-Myers Squibb. Stop reason: OPERATIONAL.

Insufficient enrollment, inability to meet protocol objectives, and slow accrual.

Phase III Kidney Transplant Recipient trial by Mark Stegall. Stop reason: OTHER/UNKNOWN.

Janssen Biotech, Inc stopped production of the vaccine, and it was no longer available as of 2023.

Phase IV Benign Prostatic Hyperplasia trial by University Hospitals Cleveland Medical Center. Stop reason: OTHER/UNKNOWN.

Lack of interest

Phase III Chronic Kidney Diseases trial by KBP Biosciences. Stop reason: EFFICACY/FUTILITY.

Interim futility analysis showed primary endpoint not achieved

Phase I Diabetic Kidney Disease trial by Mayo Clinic. Stop reason: OTHER/UNKNOWN.

Principal Investigator relocation

Phase IV Renal Dysfunction trial by Loyola University. Stop reason: OTHER/UNKNOWN.

The study was terminated by the Institutional Review Board

Phase III Regional Citrate Anticoagulation (RCA) trial by Vantive Health LLC. Stop reason: OPERATIONAL.

Study halted due to low recruitment, unrelated to safety or efficacy reasons

Phase IV Urinary Incontinence trial by Montefiore Medical Center. Stop reason: OTHER/UNKNOWN.

It was determined that it would be impracticable to conduct this study as a randomized trial. Study has been repurposed as a non-randomized study.

Phase II Congenital Adrenal Hyperplasia trial by Spruce Biosciences. Stop reason: EFFICACY/FUTILITY.

Study SPR001-203 did not meet its primary and secondary endpoints therefore Spruce Biosciences has decided to terminate the study

Early Phase I IgA Nephropathy (IgAN) trial by Jieyang People's Hospital. Stop reason: OTHER/UNKNOWN.

Due to limitation of production capacity

Phase II Hemorrhagic Fever With Renal Syndrome trial by U.S. Army Medical Research and Development Command. Stop reason: OTHER/UNKNOWN.

This was an expanded access treatment protocol that did not enroll any subjects due to no infections requiring treatment.

Phase II Chronic Kidney Disease trial by Stanford University. Stop reason: OPERATIONAL.

Lack of resources

Phase III Chronic Kidney Diseases trial by Biogen. Stop reason: OTHER/UNKNOWN.

Discontinuation of all bardoxolone chronic kidney disease programs

Phase III Autosomal Dominant Polycystic Kidney trial by Biogen. Stop reason: OTHER/UNKNOWN.

Discontinuation of all bardoxolone chronic kidney disease programs

Phase III Diabetic Kidney Disease trial by University of Colorado, Denver. Stop reason: OPERATIONAL.

Funding not available

Phase III Kidney Transplant Rejection trial by Imperial College London. Stop reason: OPERATIONAL.

Stopped at start of COVID-19 pandemic - non-feasible

Phase II Kidney Transplant Candidates trial by Fundacion Clinic per a la Recerca Biomédica. Stop reason: OTHER/UNKNOWN.

Inability to provide study drug to participants

Phase I Postoperative Urinary Retention trial by West Virginia University. Stop reason: OPERATIONAL.

technical aspects - unable to continue with the study. Investigator left institution. No patients enrolled.

Phase IV Interstitial Cystitis trial by Endeavor Health. Stop reason: OPERATIONAL.

There was a delay in recruitment initiation due to COVID-19 and internal logistical challenges. Following this delay, the principal investigator left the study site, and it was determined that the study should be terminated.

Phase II Primary IgA Nephropathy trial by Guangdong Hengrui Pharmaceutical Co., Ltd. Stop reason: OTHER/UNKNOWN.

Based on the adjustment of the R \& D strategy, the sponsor decides to terminate the research.

Phase I Diabetic Kidney Disease trial by Prokidney. Stop reason: OPERATIONAL.

business decision

Phase II Interstitial Cystitis trial by Ironwood Pharmaceuticals, Inc.. Stop reason: OPERATIONAL.

Business decision

Phase I Kidney Failure, Chronic trial by Janssen-Cilag International NV. Stop reason: OPERATIONAL.

Study 63623872FLZ1014 was terminated early based on a strategic business decision by Janssen to end the clinical development program of JNJ-63623872.

Phase IV Kidney Transplant trial by Washington University School of Medicine. Stop reason: OPERATIONAL.

poor recruitment during pandemic and after

Phase III Nephrotic Syndrome trial by University Hospital Tuebingen. Stop reason: OPERATIONAL.

Low recruiting rate and decision to evaluate as pilot study

Phase II Chronic Kidney Disease trial by AstraZeneca. Stop reason: EFFICACY/FUTILITY.

The Sponsor decided to terminate the study early due to lack of efficacy. There were no safety concerns related to the study.

Phase IV Lower Urinary Tract Symptoms trial by University of Kansas Medical Center. Stop reason: OTHER/UNKNOWN.

Not accruing patients quickly enough

Phase I Diabetic Kidney Disease trial by Mario Negri Institute for Pharmacological Research. Stop reason: OPERATIONAL.

IMP NEPHSTROM ORBECEL-M is expired and additional extension is not feasible. Low recruitment rate at Birmingham center.

Phase II Membranous Nephropathy trial by argenx. Stop reason: OPERATIONAL.

Sponsor decision

Phase II Contrast-induced Acute Kidney Injury trial by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Stop reason: OTHER/UNKNOWN.

Voluntarily suspended the trial due to strategic adjustments

Phase III Overactive Bladder (OAB) trial by Astellas Pharma Global Development, Inc.. Stop reason: EFFICACY/FUTILITY.

Termination due to operational futility

Phase IV Thoracic Diseases trial by University of Massachusetts, Worcester. Stop reason: OPERATIONAL.

inability to recruit

Phase IV Kidney Transplant Recipients trial by Astellas Pharma China, Inc.. Stop reason: OTHER/UNKNOWN.

Due to difficulty enrolling patients

Phase IV Acute Kidney Injury trial by Fernando Sanchez. Stop reason: OPERATIONAL.

Enrollment slower than anticipated and interrupted by COVID-19 pandemic

Phase I Renal Impairment trial by Pfizer. Stop reason: OPERATIONAL.

Business decision to terminate the trial after the completion of Part 1: Cohort 1 (severe renal impairment). The decision to terminate the trial was not due to any potential safety concerns.

Phase II Idiopathic Membranous Nephropathy trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor decision

Phase II End Stage Renal Disease (ESRD) trial by Iperboreal Pharma Srl. Stop reason: OPERATIONAL.

The study never started

Phase II Diabetic Kidney Disease trial by Iain Bressendorff. Stop reason: OPERATIONAL.

Slow recruitment

Phase II Chronic Kidney Disease stage4 trial by Kibow Pharma. Stop reason: OTHER/UNKNOWN.

Logistics, company reorganization

Phase II Chronic Kidney Disease stage4 trial by Kibow Pharma. Stop reason: OTHER/UNKNOWN.

Logistics, company reorganization.

Phase III Stress Urinary Incontinence trial by Cook MyoSite. Stop reason: OPERATIONAL.

Study not initiated due to business decision, no participants enrolled.

Early Phase I Acute Kidney Injury trial by University of Minnesota. Stop reason: OPERATIONAL.

Poor recruitment

Phase II Painful Bladder Syndrome trial by Urigen. Stop reason: REGULATORY.

The study was terminated due to Food and Drug Administration (FDA) recalled the heparin used in the trial because of possible contamination.

Phase II Autosomal Dominant Polycystic Kidney Disease trial by Lakefront Biotherapeutics NV. Stop reason: EFFICACY/FUTILITY.

The study was early terminated due to lack of efficacy.

Phase IV Kidney Failure, Chronic trial by University Hospital, Strasbourg, France. Stop reason: OTHER/UNKNOWN.

not enough patients

Phase II IgA Nephropathy (IgAN) trial by Alnylam Pharmaceuticals. Stop reason: OTHER/UNKNOWN.

Study was terminated early having identified clinically meaningful magnitude of proteinuria reduction due to cemdisiran (study goal). Participants completed DBT period\&were in OLE period. Sponsor had no concerns with safety\&integrity of participants.

Unknown Medication Adherence trial by Beth Israel Deaconess Medical Center. Stop reason: OPERATIONAL.

PI left organization and study not adopted by any other staff.

Phase IV Mixed Urinary Incontinence trial by Imperial College London. Stop reason: OTHER/UNKNOWN.

it stopped at a regulatory stage

Phase II Osteoporosis trial by Thomas Nickolas, MD MS. Stop reason: OPERATIONAL.

Study lost funding

Phase II Highly Sensitized Patients on Waiting List for Kidney Transplantation trial by Amgen. Stop reason: OPERATIONAL.

Stopped due to no enrollment

Unknown Narcotic Use trial by Stony Brook University. Stop reason: OPERATIONAL.

Unable to recruit desired number of patients in reasonable time frame

Phase II Kidney Transplant Rejection trial by Medeor Therapeutics, Inc.. Stop reason: OPERATIONAL.

Lack of funding