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Renal Impairment clinical trials

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NCT ID: NCT01104662 Terminated - Renal Impairment Clinical Trials

Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment

RENSE
Start date: April 19, 2010
Phase: Phase 4
Study type: Interventional

This is a multicenter, randomized, evaluator-blinded, comparator-controlled study. Participants were to be randomized (1:1) to daptomycin or comparator, stratified by degree of renal impairment (creatinine clearance [CLcr] 30 - 50 milliliters per minute [mL/min] [moderate impairment] and <30 mL/min [severe impairment]) and by type of infection (bacteremia and complicated skin and skin structure infections [cSSSI]) to create 4 cohorts defined as follows: - Cohort 1: Bacteremia and CLcr <30 mL/min - Cohort 2: Bacteremia and CLcr 30 - 50 mL/min - Cohort 3: cSSSI and CLcr <30 mL/min - Cohort 4: cSSSI and CLcr 30 - 50 mL/min Participants will be treated and evaluated for safety and microbiological and clinical efficacy in accordance with their type of infection and degree of renal impairment. Peak and trough samples will be collected to assess exposure to daptomycin for participants on Day 1 and following the 5th dose.

NCT ID: NCT00984113 Terminated - Renal Impairment Clinical Trials

Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment

Start date: September 2009
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its metabolite in patients with mild, moderate, and severe renal impairment compared to healthy volunteers.

NCT ID: NCT00958269 Terminated - Clinical trials for Type 2 Diabetes Mellitus

Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment

Start date: August 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of dutogliptin in Type 2 diabetic subjects with moderate or severe renal impairment.

NCT ID: NCT00879645 Terminated - Renal Impairment Clinical Trials

Pharmacokinetic Assessment of Sodium Sulfide in Subjects With Impaired Renal Function

Start date: August 2009
Phase: Phase 1
Study type: Interventional

This is a Phase 1 study to assess the pharmacokinetics (PK) of IK-1001 (sodium sulfide) in healthy volunteers as well as in subjects with varying degrees of impaired renal function. A total of 28 subjects will be enrolled into the study over a 6 month period. There will be 4 cohorts. The first cohort will consist of subjects with mild renal impairment, the fourth cohort will be subjects with intermediate renal impairment and the third cohort will be subjects with severe renal impairment and the second cohort will consist of normal healthy subjects. All subjects will receive the study drug for 3 hours as a single intravenous (IV) infusion and will be followed over a 7 day period.

NCT ID: NCT00793182 Terminated - Renal Impairment Clinical Trials

Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography

CINOPSIS CT
Start date: January 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.

NCT ID: NCT00787618 Terminated - Renal Impairment Clinical Trials

Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females

Start date: October 2008
Phase: Phase 1/Phase 2
Study type: Interventional

PK and safety profile of Proellex® in females with various stages of impaired renal function

NCT ID: NCT00785772 Terminated - Renal Impairment Clinical Trials

A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment

Start date: March 2010
Phase: Phase 4
Study type: Interventional

The primary objectives of this study are to evaluate the pharmacokinetics (PK) following administration of gabapentin in Japanese epileptic patients with renal impairment to confirm if there are any clinically relevant differences between the plasma gabapentin concentration simulated by population PK model, which was used for the evidence of the dose adjustment for the patients with renal impairment, and observed plasma gabapentin concentration.

NCT ID: NCT00785551 Terminated - Healthy Clinical Trials

Comparative Study of Quinine Sulfate in Healthy Patients and in Patients With Renal Impairment

Start date: November 2007
Phase: Phase 1
Study type: Interventional

The effects of mild or moderate renal impairment (creatinine clearance 30 to 50 ml/min or >50 to 80 ml/min, respectively) on the pharmacokinetic profile of quinine and its active metabolite, 3'-hydroxyquinine, will be investigated. Safety and tolerability in healthy subjects versus those with mild to moderate renal impairment will be compared, as well.