Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-associated Steatohepatitis)
NCT06939816 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-04-23
Summary
This study is designed to establish the effect of 2 doses of vonafexor on the kidney. This will be investigated in subjects with mild or moderate reduced estimated glomerular filtration rate (eGFR) and suspected MASH. In addition, the non-invasive multiparametric magnetic resonance imaging assessment of functional and structural changes in the kidney and in the liver will be investigated.
Conditions
- Chronic Kidney Disease Stage 2
- Chronic Kidney Disease Stage 3
- Metabolic Dysfunction-Associated Steatohepatitis
Interventions
- DRUG
-
Vonafexor low dose
Oral tablets
- DRUG
-
Vonafexor high dose
Oral tablets
Sponsors & Collaborators
-
Enyo Pharma
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-01
- Primary Completion
- 2025-12-22
- Completion
- 2026-03-13
Countries
- Germany
Study Locations
More Related Trials
-
A Multi-Center, Open-Label Study
NCT01468259 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function
NCT01359579 ·Status: TERMINATED ·Phase: PHASE1
-
PF-04634817 Renal Impairment Study
NCT01791855 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
NCT07315360 ·Status: RECRUITING ·Phase: PHASE1
-
Prospective Evaluation of the Incidence of NSF in Patients With Kidney Disease Undergoing MR
NCT01135316 ·Status: COMPLETED
-
A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883.
NCT06586216 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function
NCT00596518 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.
NCT00731523 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function
NCT01740362 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney Disease.
NCT03890770 ·Status: COMPLETED ·Phase: PHASE1
-
Study of the Safety, Tolerability, and Pharmacokinetics of LHW090 in Patients With Moderately Impaired Renal Function
NCT02678000 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency)
NCT02347046 ·Status: COMPLETED ·Phase: PHASE1
-
Renal Impairment Study of PF-06700841
NCT04260464 ·Status: COMPLETED ·Phase: PHASE1
-
Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer
NCT02646358 ·Status: COMPLETED ·Phase: PHASE1
-
PK Study of ACHN-490 Injection in Renally Impaired Subjects
NCT01462136 ·Status: COMPLETED ·Phase: PHASE1
-
An Ascending Dose Study to Assess Safety, Tolerability, PK/PD of LHW090 in Healthy Volunteers and in Subjects With Renal Dysfunction
NCT01846468 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of HRS-1301 Tablets in Healthy Subjects and Those With Impaired Kidney Function
NCT07322016 ·Status: RECRUITING ·Phase: PHASE1
-
Comparing the Pharmacokinetics, Safety and Tolerability of NVA237 in Renal Impairment
NCT01613690 ·Status: COMPLETED ·Phase: PHASE1
-
Study Assessing PK and Safety of MGTA-145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment
NCT04154670 ·Status: COMPLETED ·Phase: PHASE1
-
Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted
NCT03832114 ·Status: COMPLETED ·Phase: PHASE2
-
A Clinical Study of Calderasib (MK-1084) in Participants With Renal Impairment (MK-1084-010)
NCT06814119 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants With Various Degrees of Renal Function
NCT03189498 ·Status: COMPLETED ·Phase: PHASE1
-
An Open-label, Parallel-group Study to Determine the Pharmacokinetics of a Single Dose of AFQ056 in Subjects With Renal Impairment Compared to Healthy Subjects
NCT01442259 ·Status: COMPLETED ·Phase: PHASE1
-
Comparative Evaluation of Pharmacokinetics After CKD-501 Between Renal Impaired and Normal Renal Function Subjects
NCT02007941 ·Status: COMPLETED ·Phase: PHASE1
-
PK of Serelaxin in Severe Renal Impairment and ESRD
NCT01875523 ·Status: COMPLETED ·Phase: PHASE1