Study Design of 'Influence of Sarpogrelate in Patients With Renal Impairment or Diabetes Mellitus'...
Coronary Artery DiseaseDiabetes Mellitus2 moreThe purpose of the SERENADE trial is to evaluate the safety and efficacy of sarpogrelate in patients with CKD or DM after DES implantation.
A Phase I Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Renal...
Renal ImpairmentTo characterize the pharmacokinetics of LCI699 following a single oral dose in adult subjects with various degrees of impaired renal function.
Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine
Kidney Failure,ChronicThis study is a randomized, multi-center,crossover study of a domestic FM peritoneal dialysis machine and Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.
A Study to Assess the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability...
Renal ImpairmentHealthyThe purpose of this study is to evaluate the pharmacokinetics of a single dose of intranasally administered esketamine in participants with impaired renal function when compared to participants with normal renal function.
Safety Study of Cenderitide in Chronic Stable Heart Failure With Moderate Renal Impairment
Heart FailureRenal InsufficiencyCNDP-578-02 is a randomized, double-blind, placebo-controlled, dose-escalation, crossover design trial. Eight evaluable subjects (n=8) with chronic stable heart failure and moderate renal impairment will be randomized (1:1) to receive cenderitide or placebo. Enrolled subjects will begin with Infusion Period A where they will receive up to 7 days of continuous, subcutaneous, dose-escalating infusions of cenderitide or placebo via the Insulet Drug Delivery System. Enrolled subjects will then cross over into Infusion Period B where they will receive up to 7 days of continuous, subcutaneous, dose-escalating infusions of cenderitide or placebo.
Chlorthalidone in Chronic Kidney Disease
Renal InsufficiencyChronic1 moreIt is estimated that in the United States there are approximately 8 million individuals who have moderate to severe chronic kidney disease (CKD). Among them hypertension is common and is often poorly controlled due to an expanded volume state; diuretics are frequently prescribed. Loop diuretics are potent and effective in lowering blood pressure (BP) but their use is associated with acute kidney injury. Thiazide diuretics, on the other hand, are less potent, their use may be associated with less acute kidney injury, but as yet there are no firm data to support that thiazide diuretic therapy can improve BP among subjects with advanced CKD. The investigators found 13 studies on the use of thiazide diuretics in advanced CKD either alone or in combination with loop diuretics and concluded that thiazides may be useful. Thiazides cause a negative Na balance, increase Na excretion by 10-15% and weight loss by 1-2 kg in observational studies. Observational data show that thiazides lead to an improvement in seated clinic BP of about 10-15 mmHg systolic and 5-10 mmHg diastolic whereas randomized trials show about a 15 mmHg reduction in mean BP. Randomized trials had only between 7 and 23 subjects each; accordingly, larger studies are needed to evaluate their safety and efficacy in moderate to advanced CKD.
A Trial With Vinflunine in Patients With Metastatic Bladder Cancer and Impaired Renal Function
Urothelial CarcinomaBladder Cancer3 moreThis study aim to compare the efficacy, safety and quality of life of vinflunine/gemcitabine and carboplatin/gemcitabine in patients with metastatic urothelial cancer and impaired renal function.
Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Pre-dialysis Patients...
HyperkalemiaChronic Kidney FailureThe purpose of this trial is to determine if sodium polystyrene sulfonate (SPS) is an effective treatment of mild hyperkalemia in chronic kidney disease patients followed at a pre-dialysis or nephrology outpatient clinic. Subjects will be randomized to one of two treatment arms: 30 g of placebo or SPS to be taken orally once daily for seven days. The change in serum potassium levels will be compared in both treatment groups. The proportion of subjects attaining normokalemia (3.5 to 5.0 mmol/L) after seven days of treatment will also be compared. Finally, side effects will be reported for each treatment arm.
Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment
Renal ImpairmentPrimary Objective: To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics of SAR302503. Secondary Objective: To assess the tolerability of SAR302503 given as a single 300 mg dose in subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.
A Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects...
HealthyRenal ImpairmentThe main objective of the trial is to compare the pharmacokinetics of a 60 mg dose of cabozantinib in adult subjects with impaired renal function compared with healthy adult subjects. Another objective is to assess the safety and tolerability of cabozantinib in these adult subjects.