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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00275639
First received: January 10, 2006
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Liver Transplant Recipients
Drug: Cozaar
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Placebo-controlled Study of Angiotensin II Receptor Blockade to Prevent Renal Dysfunction Following Liver Transplantation.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Development of renal dysfunction (measured by iothalamate clearance).

Estimated Enrollment: 62
Study Start Date: December 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275639

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: K.V. Narayanan Menon, M.D. Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00275639     History of Changes
Other Study ID Numbers: 2085-04
Study First Received: January 10, 2006
Last Updated: January 4, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Angiotensin II
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014