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HIF-2alpha Inhibitor

Belzutifan for Kidney Failure

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Participants With ESRD: Female participants must be of nonchildbearing potential
For Participants With Healthy Renal Function: Female participants must be of nonchildbearing potential
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
Awards & highlights

Study Summary

This trial is testing a new drug, belzutifan, in people with end stage renal disease. The study will look at how well the body processes the drug and how safe and tolerable it is.

Who is the study for?
This trial is for adults with end-stage renal disease (ESRD) on stable hemodialysis and healthy individuals as controls. Participants must be in good health aside from kidney issues, not planning to conceive, and agree to use contraception. Exclusions include recent major surgery, blood donation, cancer history, significant medical conditions, or positive tests for hepatitis B/C or HIV.Check my eligibility
What is being tested?
The study is testing the drug Belzutifan at a single oral dose of 120 mg. It aims to compare how the drug behaves in the bloodstream of patients with ESRD before and after dialysis versus healthy participants. The removal of Belzutifan by dialysis will also be assessed.See study design
What are the potential side effects?
While specific side effects are not listed here, safety and tolerability of Belzutifan will be evaluated during the trial which typically includes monitoring for any adverse reactions such as nausea, headaches, allergic reactions or other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman with ESRD and cannot become pregnant.
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I am a woman who cannot become pregnant.
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I have end-stage renal disease and have been on a stable dialysis schedule of at least 3 times a week for the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apparent terminal half-life (t½) of plasma belzutifan
Area under the plasma concentration time curve of belzutifan from hour 0 to 24 (AUC0-24)
Area under the plasma concentration time curve of belzutifan from hour 0 to infinity (AUC0-inf)
+2 more
Secondary outcome measures
Dialysis clearance of belzutifan based on plasma (CLD, plasma)
Number of participants who discontinued from the study due to an AE
Number of participants who experienced an adverse event (AE)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Belzutifan in Participants with ESRDExperimental Treatment1 Intervention
Participants with ESRD will receive a single dose of belzutifan 120 mg orally on Day 1 of a 4-day treatment period (Period 1), followed by a ≥7 day washout period. Participants receive another single dose of belzutifan 120 mg orally on Day 1 of a 4-day treatment period (Period 2).
Group II: Belzutifan in Healthy ParticipantsExperimental Treatment1 Intervention
Participants in the healthy matched control group will receive a single dose of belzutifan 120 mg orally on Day 1 of a 4-day treatment period (Period 1).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belzutifan
2018
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,269 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,055,043 Total Patients Enrolled
1 Trials studying Kidney Failure
8 Patients Enrolled for Kidney Failure
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,850 Total Patients Enrolled

Media Library

Belzutifan (HIF-2alpha Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04994522 — Phase 1
Belzutifan (HIF-2alpha Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04994522 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial include persons aged 55 and above?

"This research is open to individuals that are at least 18 years old and younger than 75."

Answered by AI

How many participants are being monitored in this experiment?

"Affirmative. The details posted on clinicaltrials.gov attest to the fact that this medical study, whose initial posting was July 12th 2022, is actively seeking participants. Precisely 12 patients must be enrolled from one healthcare facility."

Answered by AI

Has Belzutifan been verified by the FDA?

"Belzutifan's safety is estimated to be a 1 given that this is an early-stage clinical trial with limited evidence of efficacy and associated risk."

Answered by AI

Has there been any prior experimentation with this particular clinical study?

"Presently, 16 clinical trials for Belzutifan are ongoing in 372 cities across 44 nations. The initial study sponsored by Peloton Therapeutics, Inc., began in 2016 and involved 120 participants who completed the Phase 1 drug approval process. Since that time, one additional trial has been concluded."

Answered by AI

Are there any prior studies that have used Belzutifan to explore treatment options?

"Presently, 16 different medical trials are being conducted on Belzutifan. 3 of these active studies are in the final Phase before approval. Whilst most research is taking place at Cardiff, Wales, there are 859 total clinical trial sites operating experiments pertaining to this medication."

Answered by AI

To what extent has Belzutifan been found to be efficacious in treating patients?

"Belzutifan is a viable treatment option for malignant neoplasms, anemia, sickle cell illness, and von hippel lindau disease."

Answered by AI

Are there any qualifications I must meet to participate in this clinical experiment?

"In order to be accepted in this study, those aged between 18 and 75 should present with renal failure. This trial is taking on 12 participants in total."

Answered by AI

Are there any current vacancies for participants in this medical experiment?

"As per the data on clinicaltrials.gov, this medical trial is currently searching for suitable individuals to take part in the study. The details of which have been available since July 12th 2022 and were last updated a week later."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)
2022. "A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04994522.
~5 spots leftby Apr 2025
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