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Renal Impairment clinical trials

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NCT ID: NCT06318676 Not yet recruiting - Renal Impairment Clinical Trials

A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment

Start date: March 15, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.

NCT ID: NCT06295796 Not yet recruiting - Renal Impairment Clinical Trials

A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)

Start date: June 24, 2024
Phase: Phase 1
Study type: Interventional

The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study.

NCT ID: NCT05731804 Not yet recruiting - Hepatic Impairment Clinical Trials

Hepatic Impairment and Renal Impairment Study of SIM0417 Combined With Ritonavir

Start date: March 1, 2023
Phase: Phase 1
Study type: Interventional

This is a multicenter, nonrandomized, open-label, parallel controlled Phase I clinical study to evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417 combined with ritonavir after a single dose in subjects with mild and moderate renal impairment, moderate hepatic impairment, normal renal function, and normal hepatic function. It is divided into Part A (subjects with mild/moderate renal impairment and subjects with normal renal function) and Part B (subjects with moderate hepatic impairment and subjects with normal hepatic function).

NCT ID: NCT05556135 Not yet recruiting - Renal Impairment Clinical Trials

Role Of Serum Adiponectin In The Ealy Detection Of Renal Impairment In Patients With Non Alcoholic Fatty Liver Disease

Start date: October 1, 2022
Phase:
Study type: Observational [Patient Registry]

Early detection of renal impairment in patients with Non-alcoholic fatty liver disease and its correlation with serum Adiponectin level.

NCT ID: NCT05298683 Not yet recruiting - Multiple Myeloma Clinical Trials

A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor

Start date: May 2022
Phase: Phase 2
Study type: Interventional

This is an investigator-initiated (IIS), phase 2, prospective, open-label, multinational study, designed to be conducted in approximately 14 sites. Eligible patients will initially receive six 28-day cycles of isatuximab, pomalidomide, and low-dose dexamethasone. Following this phase: Patients who achieve ≥VGPR will be randomized in a 1:1 ratio to receive isatuximab, given either Q2W or once monthly, plus pomalidomide and low-dose dexamethasone. Patients with <VGPR will continue treatment with isatuximab Q2W, pomalidomide, and low-dose dexamethasone. The study will last for 42 months (recruitment and follow-up period), starting from the date of the first patient in (FPI) to the date of the last patient last visit (LPLV). Core study procedures consist of baseline and post-baseline safety and disease evaluations, including physical examination, hematologic/clinical chemistry tests, radiologic assessments, bone marrow evaluations, and blood/urine M-protein assessments. Patients will be allowed to continue treatment until disease progression, death, unacceptable AEs, lost to follow-up, or consent withdrawal.

NCT ID: NCT05147493 Not yet recruiting - Multiple Myeloma Clinical Trials

A Phase 2 Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide and Dexamethasone Followed by Isatuximab and Lenalidomide Maintenance in Newly Diagnosed Patients With Multiple Myeloma and Severe Renal Impairment

Start date: April 2022
Phase: Phase 2
Study type: Interventional

This is an Investigator-Initiated, phase 2, prospective, open-label study designed to be conducted in six hospitals in Greece. Eligible patients will initially receive an induction phase of six 28-day cycles of isatuximab in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd), followed by a maintenance phase with isatuximab and lenalidomide until disease progression, death, unacceptable adverse events, lost to follow up, or consent withdrawal, whichever occurs first. The study will last for approximately 36 months (follow-up period), starting from the date of the first patient in, to the date of the last patient last visit. The primary objective is to assess the effect of induction treatment with isatuximab in combination with VCd on the renal function of newly diagnosed patients with multiple myeloma and severe renal impairment (RI). The secondary objectives are to evaluate the effect of isatuximab in combination with VCd, followed by lenalidomide maintenance on: Overall response rate, Progression-Free Survival, Time to Response, Duration of Response, Overall Survival, Minimal Residual Disease negativity rate, Safety

NCT ID: NCT04249908 Not yet recruiting - Renal Impairment Clinical Trials

Pharmacokinetics of Besifovir in Adults With Normal and Impaired Renal Function

Start date: February 13, 2020
Phase: Phase 1
Study type: Interventional

This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of Besifovir and its metabolite, LB80331, in participants with normal and impaired renal function

NCT ID: NCT03896750 Not yet recruiting - Tuberculosis Clinical Trials

Single-Dose Study to Evaluate the PKs of Pretomanid in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

Start date: December 7, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, single dose, sequential group study to compare the safety and pharmacokinetics of pretomanid in the following groups of subjects: 1) subjects with severe renal impairment including those with End Stage Renal Disease (ESRD) not needing dialysis, and subjects with mild or moderate renal impairment, designated as Groups 2, 3, and 4, respectively; and 2) subjects with normal renal function matched to the above renal impairment groups, designated as Groups 1A, 1B, and 1C, respectively. The study will be conducted following a reduced Pharmacokinetic (PK) study design in Part A and Part B. Part A will enroll subjects from Group 1A (i.e., 6 healthy matched controls) and Group 2 (i.e., 6 subjects with severe renal impairment and ESRD, not on dialysis). A decision will be made after the PK of pretomanid and safety of subjects enrolled in Part A have been reviewed. If Part A demonstrated different pretomanid exposures at least a 50-100% increase in Area under the Curve (AUC) in Group 2 (severe renal impairments and ESRD, not on dialysis) relative to the exposures in Group 1A (matched subjects with normal renal function), then the reduced PK study will extend to the full PK study to enroll subjects into Part B (i.e., to investigate mild, and moderate renal impairment) and all enrollment will be initiated concurrently in Part B groups (1B, 1C, 3 and 4). If no difference in PK and safety is observed in Part A, then no further study (Part B) is recommended The approximate patient involvement will be 3 months. The primary objective is to evaluate the PK profiles of pretomanid in plasma and urine after a single oral dose of 200 mg in subjects with renal impairment compared to matched healthy controls.

NCT ID: NCT03330054 Not yet recruiting - Type2 Diabetes Clinical Trials

Frequency Of Eye Problems In Type 2 Diabetes With Chronic Kidney Disease

Start date: December 1, 2017
Phase: N/A
Study type: Observational

This study evaluate the frequency and type of eye problem among Type 2 Diabetics with renal impairment and effect of renal impairment and haemodialysis on diabetic retinopathy