A Study on the Effect of Kidney Disease… | Clinical Trial

Key information

Conditions

Renal Insufficiency Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemic and Lymphatic Diseases Hemodialysis Immune System Diseases Immunoproliferative Disorders Kidney Diseases Kidney Failure, Chronic Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and non-pregnant females with a clinical diagnosis of renal insufficiency with mild, moderate, severe or end stage renal disease on hemodialysis
A body mass index of less than 40 kg per meter squared (body weight in kg divided by height in meters squared)
Smokes less than 10 cigarettes/day

Exclusion criteria

Patients with uncontrolled diabetes or uncontrolled congestive heart failure
Patient has abnormal prestudy laboratory measurements including serum potassium or white blood counts
Patient has systolic blood pressure below 100 mm Hg or above 180 mm Hg
Patient has diastolic blood pressure less than 50 mm Hg systolic or above 100 mmHg

Treatment and study plan

MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days

Drug

Primary outcomes

Determination of the pharmacokinetics of MK0431 (sitagliptin phosphate) in patients with renal insufficiency compared to healthy volunteers

Secondary outcomes

Safety and tolerability in patients with renal insufficiency

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open- Label, 2 Part Study to Investigate the Pharmacokinetics, Safety, and Tolerability of MK0431(Sitagliptin Phosphate) in Patients With Varying Degrees of Renal Insufficiency

Important dates

Study start: 2003
Primary completion: 2003
Study completion: 2003
First posted: Jan 4, 2007
Registry last updated: Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed