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Impaired Renal Function clinical trials

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NCT ID: NCT04620590 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

An Open Label Phase IV Study to Evaluate Dapagliflozin Treatment in Type 2 Diabetes Mellitus Patients With Impaired Renal Function

Start date: April 20, 2021
Phase: Phase 4
Study type: Interventional

Open label, mechanistic, single-arm study to evaluate the natriuretic effect of 2 weeks dapagliflozin treatment in T2DM patients with impaired renal function. It will measure the average change in 24-hr sodium excretion from average Baseline to average values at Day 2 to 4 within the study group. The study will allow for an up to 6-week Screening and Run-in Period, a 2-week Treatment Period and a 5-day Follow-up Period. Patients will consume food from standardized food boxes starting on Day -6 (patients not on insulin) or Day -20 at the earliest (patients on insulin) of the study until Day 18 (inclusive). Eligible patients will receive dapagliflozin 10 mg tablets once daily for 14±1 days starting on Day 1. This will be followed by a Follow-up Period of 5 days.

NCT ID: NCT04252430 Terminated - Healthy Volunteers Clinical Trials

RI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Renal Impaired Patients and Healthy Subjects

Start date: October 9, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1, multicentric, open-label,two arms to assess and compare the effect of single oral administration of MD1003 on the pharmacokinetic parameters in renal impaired patients and healthy subjects with normal renal function. The planned enrollment is 36 subjects (18 impaired patients and 18 healthy subjects).

NCT ID: NCT04179630 Completed - Clinical trials for Impaired Renal Function

Study of Aldafermin (NGM282) in Participants With Impaired Renal Function

Start date: November 8, 2019
Phase: Phase 1
Study type: Interventional

This is a single-center evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Renal Function.

NCT ID: NCT03776539 Completed - Clinical trials for Impaired Renal Function

A Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02

Start date: January 4, 2019
Phase: Phase 1
Study type: Interventional

Phase 1 - Pharmacokinetics in Patients with Impaired Renal Function

NCT ID: NCT02965040 Completed - Clinical trials for Impaired Renal Function

A Phase 1 Study of Roxadustat in Subjects With Different Degrees of Renal Function

Start date: December 12, 2016
Phase: Phase 1
Study type: Interventional

For subjects with normal renal function or severely impaired renal function, this study will evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma and urine. For subjects with end stage renal disease (ESRD) on continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD), this study will evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma, urine and dialysate. For subjects with ESRD on hemodialysis (HD) or hemodiafiltration (HDF), this study will evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma, urine and dialysate and also the effect of dialysis on the pharmacokinetics of roxadustat and its main metabolites.

NCT ID: NCT02467478 Completed - Type 2 Diabetes Clinical Trials

Linagliptin's Effect on CD34+ Stem Cells

Start date: April 2015
Phase: Phase 4
Study type: Interventional

Type 2 diabetes is a national epidemic. Diabetes has undesirable effects on blood vessels which may contribute to heart disease. Endothelial Progenitor Cells (EPCs) are found in the blood. Research has shown that improving the survival of these special blood cells may decrease the harmful effects of diabetes on blood vessels and reduce or reverse heart disease. Linagliptin is an Food and Drug Administration (FDA) approved prescription medicine used along with insulin or with oral medications to lower blood sugar in people with Type 2 diabetes. It is in a class of diabetes medication called Dipeptidyl peptidase-4 (DPP-4) inhibitors. DPP-4 inhibitors have been shown to increase EPCs in patients with Type 2 diabetes. Hypothesis: Both type 2 diabetes and Chronic Kidney Disease (CKD) are associated with poor stem cell number and function. Poor viability and function of EPCs in CKD and diabetes The investigators hypothesize that use of Linagliptin (along with Insulin) may help reduce cardiovascular risk by improving EPC survival and function above and beyond adequate glucose metabolism control

NCT ID: NCT02431481 Completed - Clinical trials for Impaired Renal Function

Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011

Start date: October 23, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the PK and safety profile of LEE011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal renal function.

NCT ID: NCT02087566 Completed - Renal Failure Clinical Trials

Linezolid Pharmacokinetics In Patients With Impaired Renal Function (PPT6)

LZDPPT6
Start date: October 2013
Phase: N/A
Study type: Interventional

Renal failure patients were treated with linezolid (LZD) for proven or suspected infections by multiresistant Gram-positive cocci. The aim of this study is to determine if dose adjustment of LZD is needed as a function of renal impairment or not, especially that a significant component of LZD is eliminated unchanged in urine.

NCT ID: NCT01760031 Active, not recruiting - Clinical trials for Impaired Renal Function

Longterm Follow-up After Remote Ischemic Preconditioning for Prevention of Contrast-induced Nephropathy

RenProLong
Start date: July 2012
Phase: N/A
Study type: Observational

Remote ischemic preconditioning reduces the incidence of contrast-induced acute kidney injury in patients undergoing elective coronary angiography. This study was designed to acquire long-term data of initially randomized patients in the RenPro Trial.

NCT ID: NCT01716455 Completed - Clinical trials for Impaired Renal Function

Study of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function

Start date: October 29, 2012
Phase: Phase 1
Study type: Interventional

Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias. The primary purpose of the study is to assess the pharmacokinetics of SSP-004184 (FBS0701) following a single 75mg/kg dose of SSP-004184 (FBS0701) in healthy adults and elderly subjects and in adult subjects with mild, moderate, severe, and end stage renal disease (ESRD) degrees of impaired renal function. The results of this study will characterize the pharmacokinetics, safety, and tolerability of SSP-004184 (FBS0701) in adult subjects with various degrees of renal impairment, and these data will be compared to healthy adult and elderly subjects.