The Effects of Angiotensin II Receptor Blockade on Kidney Function and Scarring After Liver Transplant

Liver Transplant Recipients Clinical Trial

Official title:

A Randomized, Double-blinded, Placebo-controlled Study of Angiotensin II Receptor Blockade to Prevent Renal Dysfunction Following Liver Transplantation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275639
• Other study ID #: 2085-04
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2006
• Last updated: January 4, 2012
• Start date: December 2004
• Est. completion date: August 2007

Study information

• Verified date: January 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This research study is being done to study the effects, both good and bad, of calcineurin inhibitors and the drug Cozaar (losartan), on kidney function and kidney scarring following a liver transplant.

Description:

This study is a double-blinded, placebo controlled trial to help determine the pathogenesis of chronic renal dysfunction in patients undergoing liver transplantation. It will examine the renal function and renal morphology in patients on calcineurin inhibitors and the effects of Cozaar (losartan) following liver transplantation. Participants will have blood, urine and iothalamate clearance test, to look at kidney function prior to transplant. At the time of transplant, kidney biopsies will be performed in the operating room under anesthesia. Participants will be in the study for one year. At three weeks following liver transplant, participants will be randomly assigned to receive either a placebo (inactive drug) or the study drug (losartan). The participant will need to continue to return to the clinic at the normal scheduled intervals. During these times blood and urine tests will be done. A kidney biopsy will be performed at the yearly exam and study pills will be stopped. The researchers will continue to follow participant's creatine measurements for the next 10 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Participants who will be undergoing a liver transplant and are between the ages of 18 to 70 years of age.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Transplant Recipients

Intervention

Drug:
• Cozaar

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of renal dysfunction (measured by iothalamate clearance).