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

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ClinicalTrials.gov Identifier: NCT00275639
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : January 6, 2012
Sponsor:
Information provided by:
Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Transplant Recipients Drug: Cozaar Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Placebo-controlled Study of Angiotensin II Receptor Blockade to Prevent Renal Dysfunction Following Liver Transplantation.
Study Start Date : December 2004
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine





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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria
Participants who will be undergoing a liver transplant and are between the ages of 18 to 70 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00275639     History of Changes
Other Study ID Numbers: 2085-04
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Angiotensin II
Angiotensinogen
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action