End Stage Renal DiseasePhase 1NCT04994522

A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)

A Phase 1 study testing Belzutifan in people with End Stage Renal Disease and Renal Impairment, run by Merck Sharp & Dohme LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: End Stage Renal Disease, Renal Impairment
What is being tested?: Belzutifan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 12 Jul 2022to 11 Apr 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

For Participants With Healthy Renal Function
Is in good health based on the opinion of the investigator.
Male participants agree to remain abstinent from heterosexual intercourse on a long-term basis or must agree to use contraception as instructed.
Female participants must be of nonchildbearing potential.
For Participants With end stage renal disease (ESRD)
With exception of the renal impairment, is in good health based on the opinion of the investigator.

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Has ESRD maintained on stable regimen of at least 3 times per week hemodialysis (HD) for at least 3 months prior to the initial administration of the study intervention.
Male participants agree to remain abstinent from heterosexual intercourse on a long-term basis or must agree to use contraception as instructed.
Female participants must be of nonchildbearing potential.

Who cannot join

For Participants With Healthy Renal Function
Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
Has a history of cancer (malignancy).
Is positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
Has received any non-live vaccine starting from 14 days prior to study intervention or is scheduled to receive any non-live vaccine through 30 days following study intervention (except coronavirus disease 2019 [COVID-19]).

Show all 12Show fewer

Participants With ESRD
Has a history of cancer (malignancy).
Has required frequent emergent HD (≥3) within a year prior to the initial dose of study intervention.
Is positive for HBsAg, hepatitis C antibodies, or HIV.
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
Has received any non-live vaccine starting from 14 days prior to study intervention or is scheduled to receive any non-live vaccine through 30 days following study intervention (except COVID-19)

Trial locations and contacts

1 site in 1 country.

United States1 site

Orlando Clinical Research Center ( Site 0001)
Orlando, Florida, 32809

Other trials in United States

About this study

Official title: An Open-Label, Single-Dose Study to Investigate the Influence of Renal Impairment on the Pharmacokinetics of MK-6482

The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 120 mg dose in participants with end stage renal disease (ESRD) before and after hemodialysis (HD) to each other and also to that of healthy matched control participants. This study will also evaluate the safety and tolerability of a single oral 120 mg dose of belzutifan in participants with ESRD and the extent of belzutifan removed by HD.

Conditions: End Stage Renal Disease, Renal Impairment
Being tested: Belzutifan
Medical subject headings: Kidney Failure, Chronic, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BelzutifanDrug
Also called MK-6482, PT2977, WELIREG
Three 40 mg tablets given as a single oral 120 mg dose.

Study groups in NCT04994522
Study group	Role	What they receive
Belzutifan in Participants with ESRD	Experimental	In period 1, participants with ESRD will receive a single, oral dose of belzutifan 120 mg on Day 1 after HD. In period 2, participants with ESRD will receive a single, oral dose of belzutifan 120 mg on Day 1 before HD. Each period is 4 days. Receives: Drug: Belzutifan
Belzutifan in Healthy Participants	Experimental	In period 1, healthy participants will receive a single, oral dose of belzutifan 120 mg on Day 1 of a 4-day period. Receives: Drug: Belzutifan

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration Time Curve of Belzutifan From Hour 0 to Infinity (AUC0-inf)
AUC0-inf was defined as the area under the concentration-time curve of belzutifan from time zero to infinity. Blood samples collected predose and at multiple timepoints postdose were used to determine AUC0-inf of belzutifan in plasma.
Measured: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
Area Under the Plasma Concentration Time Curve of Belzutifan From Hour 0 to 24 (AUC0-24)
AUC0-24 was defined as the area under the concentration-time curve of belzutifan from time zero to 24 hours postdose. Blood samples collected predose and at multiple timepoints postdose were used to determine AUC0-24 of belzutifan in plasma.
Measured: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, and 24 hours postdose
Maximum Plasma Concentration (Cmax) of Belzutifan
Cmax is the maximum concentration of belzutifan observed in plasma. Blood samples collected predose and at multiple timepoints postdose were used to determine Cmax of belzutifan in plasma.
Measured: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
Time to Maximum Plasma Concentration (Tmax) of Belzutifan
Tmax is the amount of time that belzutifan is present at the maximum concentration observed in plasma. Blood samples collected predose and at multiple timepoints postdose were used to determine Tmax of belzutifan in plasma.
Measured: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
Apparent Terminal Half-life (t½) of Plasma Belzutifan
t1/2 is defined as the time required to divide plasma concentration of belzutifan by half. Blood samples collected predose and at multiple timepoints postdose were used to determine the apparent terminal t1/2 of belzutifan in plasma.
Measured: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose

Secondary outcomes (3)

Dialysis Clearance of Belzutifan Based on Plasma (CLD, Plasma)
CLD, plasma is defined as a measure of the extent of belzutifan removed by HD. Blood samples collected at pre-dialysis and at multiple timepoints post-dialysis were used to measure the extent of belzutifan in plasma removal by HD.
Measured: Pre-dialysis, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours post-dialysis on Day 1 of Period 2 (Study Day ~12)
Percentage of Participants Who Experienced an Adverse Event (AE)
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who experienced an AE are reported.
Measured: Up to 32 days
Percentage of Participants Who Discontinue Study Intervention Due to an AE
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who discontinue study intervention due to an AE are reported.
Measured: Up to 12 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 202211 Apr 2024

First posted6 Aug 2021
Study start12 Jul 2022
Primary completion1 Apr 2024
Study completion11 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04994522
Sponsor's protocol ID: 6482-021
Other IDs: MK-6482-021
Status last verified: Mar 2025
First submitted: 2 Aug 2021
Last updated: 6 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-Dose Study to Investigate the Influence of Renal Impairment on the Pharmacokinetics of MK-6482
ClinicalTrials.gov ID: NCT04994522
Acronym / sponsor ID: 6482-021
Conditions: End Stage Renal Disease, Renal Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 12 Jul 2022 (actual)
Primary completion: 1 Apr 2024 (actual)
Study completion: 11 Apr 2024 (actual)
First posted: 6 Aug 2021 (actual)
Results: Posted 6 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Belzutifan in Participants with ESRD	Experimental	Drug: BelzutifanIn period 1, participants with ESRD will receive a single, oral dose of belzutifan 120 mg on Day 1 after HD. In period 2, participants with ESRD will receive a single, oral dose of belzutifan 120 mg on Day 1 before HD. Each period is 4 days.
Belzutifan in Healthy Participants	Experimental	Drug: BelzutifanIn period 1, healthy participants will receive a single, oral dose of belzutifan 120 mg on Day 1 of a 4-day period.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

For Participants With Healthy Renal Function
Is in good health based on the opinion of the investigator.
Male participants agree to remain abstinent from heterosexual intercourse on a long-term basis or must agree to use contraception as instructed.
Female participants must be of nonchildbearing potential.
For Participants With end stage renal disease (ESRD)

Key exclusion criteria (12 listed)

For Participants With Healthy Renal Function
Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
Has a history of cancer (malignancy).
Is positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BelzutifanAlso: MK-6482, PT2977, WELIREGThree 40 mg tablets given as a single oral 120 mg dose.	Drug	Belzutifan in Healthy Participants, Belzutifan in Participants with ESRD

Primary outcome

Area Under the Plasma Concentration Time Curve of Belzutifan From Hour 0 to Infinity (AUC0-inf)
Time frame: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
AUC0-inf was defined as the area under the concentration-time curve of belzutifan from time zero to infinity. Blood samples collected predose and at multiple timepoints postdose were used to determine AUC0-inf of belzutifan in plasma.
Area Under the Plasma Concentration Time Curve of Belzutifan From Hour 0 to 24 (AUC0-24)
Time frame: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, and 24 hours postdose
AUC0-24 was defined as the area under the concentration-time curve of belzutifan from time zero to 24 hours postdose. Blood samples collected predose and at multiple timepoints postdose were used to determine AUC0-24 of belzutifan in plasma.
Maximum Plasma Concentration (Cmax) of Belzutifan
Time frame: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
Cmax is the maximum concentration of belzutifan observed in plasma. Blood samples collected predose and at multiple timepoints postdose were used to determine Cmax of belzutifan in plasma.
Time to Maximum Plasma Concentration (Tmax) of Belzutifan
Time frame: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
Tmax is the amount of time that belzutifan is present at the maximum concentration observed in plasma. Blood samples collected predose and at multiple timepoints postdose were used to determine Tmax of belzutifan in plasma.
Apparent Terminal Half-life (t½) of Plasma Belzutifan
Time frame: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
t1/2 is defined as the time required to divide plasma concentration of belzutifan by half. Blood samples collected predose and at multiple timepoints postdose were used to determine the apparent terminal t1/2 of belzutifan in plasma.

3 secondary outcomes

Dialysis Clearance of Belzutifan Based on Plasma (CLD, Plasma)
Time frame: Pre-dialysis, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours post-dialysis on Day 1 of Period 2 (Study Day ~12)
Percentage of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to 32 days
Percentage of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to 12 days

Results and safety

Results posted to the registry on 6 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Belzutifan in Participants With ESRD	8	8
Belzutifan in Healthy Participants	6	6

Primary outcome: Area Under the Plasma Concentration Time Curve of Belzutifan From Hour 0 to Infinity (AUC0-inf)

Time frame: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng•hr/mL

Measure	Belzutifan in Participants With ESRD Before HD (Period 2) n = 7	Belzutifan in ESRD After HD (Period 1) n = 8	Belzutifan in Healthy Participants n = 6
Value	17100 (91.3)	21100 (91.3)	18500 (41.4)

Population analysed: All participants who are compliant with the study procedure and have available data considered sufficient to exhibit the effect of treatment.

Primary outcome: Area Under the Plasma Concentration Time Curve of Belzutifan From Hour 0 to 24 (AUC0-24)

Time frame: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, and 24 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng•hr/mL

Measure	Belzutifan in Participants With ESRD Before HD (Period 2) n = 7	Belzutifan in Participants With ESRD After HD (Period 1) n = 8	Belzutifan in Healthy Participants n = 6
Value	10700 (50.5)	12300 (50.7)	13200 (30.7)

Population analysed: All participants who are compliant with the study procedure and have available data considered sufficient to exhibit the effect of treatment.

Primary outcome: Maximum Plasma Concentration (Cmax) of Belzutifan

Time frame: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Belzutifan in Participants With ESRD Before HD (Period 2) n = 7	Belzutifan in Participants With ESRD After HD (Period 1) n = 8	Belzutifan in Healthy Participants n = 6
Value	1110 (44.0)	907 (46.7)	1300 (26.1)

Population analysed: All participants who are compliant with the study procedure and have available data considered sufficient to exhibit the effect of treatment.

Primary outcome: Time to Maximum Plasma Concentration (Tmax) of Belzutifan

Time frame: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose. Median (Full Range). Unit: hour

Measure	Belzutifan in Participants With ESRD Before HD (Period 2) n = 7	Belzutifan in Participants With ESRD After HD (Period 1) n = 8	Belzutifan in Healthy Participants n = 6
Value	2.00 (1.00 to 3.00)	4.00 (1.50 to 9.00)	1.00 (0.50 to 3.00)

Population analysed: All participants who are compliant with the study procedure and have available data considered sufficient to exhibit the effect of treatment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 32 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Belzutifan in Participants With ESRD Before HD (Period 2)	1 of 7 (14.3%)	0 of 7 (0%)	0 of 7
Belzutifan in Participants With ESRD After HD (Period 2)	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Belzutifan in Healthy Participants	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Belzutifan in people with End Stage Renal Disease and Renal Impairment, run by Merck Sharp & Dohme LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration Time Curve of Belzutifan From Hour 0 to Infinity (AUC0-inf) (time frame: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04994522.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.