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Renal Impairment clinical trials

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NCT ID: NCT04909853 Completed - Renal Impairment Clinical Trials

Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function.

Start date: June 15, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1, non-randomized, open-label, 2-part study to investigate the effect of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF-07321332 in combination with the PK boosting agent ritonavir. Participants will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: will be conducted in approximately 24 participants (approximately 8 per group) with stable mild or moderate renal impairment and a control group of participants with normal renal function. Part 2 will be conducted in approximately 8 participants with stable severe renal impairment.

NCT ID: NCT04865393 Completed - Renal Impairment Clinical Trials

Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function

Start date: June 8, 2021
Phase: Phase 1
Study type: Interventional

Evaluation of the pharmacokinetics (PK) of SPR206 in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy.

NCT ID: NCT04859439 Completed - Renal Impairment Clinical Trials

A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Renal Impairment

Start date: June 15, 2021
Phase: Phase 1
Study type: Interventional

This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild, moderate, severe renal impairment and subjects with kidney failure compared to the matched control subjects with normal renal function.

NCT ID: NCT04810598 Completed - Renal Impairment Clinical Trials

Study to Assess Adverse Events and the Movement of Oral Venetoclax Tablet Through the Body of Female Participants Aged 18-75 Years With Impaired Renal Function

Start date: July 8, 2021
Phase: Phase 1
Study type: Interventional

Renal insufficiency is common in participants with blood cancers. The main objective of this study is to evaluate adverse events and movement of oral venetoclax tablets through the body of female participants with severe normal renal function and those with end stage renal disease (ESRD) requiring hemodialysis. Venetoclax is an investigational drug being developed for the treatment of various hematologic malignancies. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. Approximately 12 female participants between 18 and 75 years, with Body Mass Index (BMI) between 18 to 42 kg/m2 will be enrolled in approximately 4 sites across the world. Participants with normal renal function will receive single dose of oral venetoclax tablet. Participants with ESRD will receive oral venetoclax tablets just prior to hemodialysis (Period 1 Day 1) and between dialysis days (Period 2 Day 1), doses in the two periods will be separated by at least 7 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and urine tests, checking for side effects.

NCT ID: NCT04755088 Completed - Renal Impairment Clinical Trials

Surufatinib Renal Impairment Study

Start date: February 12, 2021
Phase: Phase 1
Study type: Interventional

An open-label, multicenter, single-dose, single-period, sequential study to assess the effect of moderate renal impairment on the pharmacokinetics of surufatinib.

NCT ID: NCT04656795 Completed - Renal Impairment Clinical Trials

PK Study in Subjects With Renal Impairment (Severe and if Required Mild & Moderate) Compared to Subjects With Normal Renal Function

Start date: December 2, 2020
Phase: Phase 1
Study type: Interventional

This is an open-label, non randomised, single-dose, study in male and female subjects with renal impairment (severe and if required mild & moderate) compared to male and female subjects with normal renal function.

NCT ID: NCT04646889 Completed - Renal Impairment Clinical Trials

Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment

Start date: January 14, 2021
Phase: Phase 1
Study type: Interventional

This is a 2-segment, multi-center, phase 1, open-label, study evaluating the pharmacokinetics and pharmacodynamics of AR882 in subjects with various degrees of renal impairment.

NCT ID: NCT04623710 Completed - Healthy Clinical Trials

Study of ALXN2050 in Participants With Renal Impairment

Start date: July 8, 2021
Phase: Phase 1
Study type: Interventional

This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with impaired renal function.

NCT ID: NCT04616677 Completed - Renal Impairment Clinical Trials

A Study to Evaluate the Effect of Renal Impairment on JNJ-42847922 in Adult Participants

Start date: March 31, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetic of a single oral dose of JNJ-42847922 in adult participants with renal impairment compared with healthy participants with normal renal function.

NCT ID: NCT04616027 Completed - Healthy Clinical Trials

STUDY OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT AND PARTICIPANTS WITHOUT RENAL IMPAIRMENT

Start date: January 13, 2021
Phase: Phase 1
Study type: Interventional

This study will characterize the effect of varying degrees of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF- 06882961 compared with participants with normal renal function.