Belzutifan for Kidney Failure

Orlando Clinical Research Center ( Site 0001), Orlando, FL
Kidney Failure+1 More ConditionsBelzutifan - Drug
Eligibility
18 - 75
All Sexes

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.

Eligible Conditions
  • Kidney Failure

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

5 Primary · 3 Secondary · Reporting Duration: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose

Day 1
Dialysis clearance of belzutifan based on plasma (CLD, plasma)
Hour 72
Apparent terminal half-life (t½) of plasma belzutifan
Area under the plasma concentration time curve of belzutifan from hour 0 to infinity (AUC0-inf)
Maximum plasma concentration (Cmax) of belzutifan
Time to maximum plasma concentration (Tmax) of belzutifan
Hour 24
Area under the plasma concentration time curve of belzutifan from hour 0 to 24 (AUC0-24)
Day 29
Number of participants who discontinued from the study due to an AE
Number of participants who experienced an adverse event (AE)

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Belzutifan in Participants with ESRD
1 of 2
Belzutifan in Healthy Participants
1 of 2

Experimental Treatment

12 Total Participants · 2 Treatment Groups

Primary Treatment: Belzutifan · No Placebo Group · Phase 1

Belzutifan in Participants with ESRD
Drug
Experimental Group · 1 Intervention: Belzutifan · Intervention Types: Drug
Belzutifan in Healthy Participants
Drug
Experimental Group · 1 Intervention: Belzutifan · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belzutifan
FDA approved

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,737 Previous Clinical Trials
4,973,818 Total Patients Enrolled
1 Trials studying Kidney Failure
8 Patients Enrolled for Kidney Failure
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,578,383 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,670 Previous Clinical Trials
7,959,200 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.