Diabetes and Kidney Disease |
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Clinical Trial: Angiotensin II Blockade
This study is currently recruiting patients.
Purpose
Chronic allograft nephropathy continues to be a major cause of kidney transplant loss and return to dialysis. Treatment options are limited and the course of the disease tends to be progressive. This trial is designed to prevent a major mediator of this process, namely the expansion of the cortical interstitial compartment of the kidney where most of the scarring occurs. The drug being studied, Losartan, has proven efficacious in a number of kidney diseases.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Kidney Disease Proteinuria | Drug: Losartan | Phase IV |
MedlinePlus related topics: Kidney Diseases
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Angiotensin II Blockade for the Prevention of Cortical Interstitial Expansion and Graft Loss in Kidney Transplant Recipients
Expected Total Enrollment: 136
Study start: December 2002; Expected completion: December 2007
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Age > 18 years.
- Recipients of a first or a second renal transplant alone or in combination with a pancreas transplantation.
- Informed consent
- Adequate baseline biopsy; at least 10 cortical projection fields.
Exclusion Criteria:
- Age < 18 years.
- Serum creatinine 2.5mg/dL.
- Persistent hyperkalemia; potassium > 5.4 mEq/L.
- Known hypersensitivity to losartan or iodine allergy.
- Documented renal artery stenosis by duplex ultrasonography.
- Recipients of grafts from an HLA-identical sibling.
- Recipients whose primary renal disease is primary hyperoxaluria,dense-deposit disease, focal segmental glomerulosclerosis or hemolytic uremic syndrome.
- Women of childbearing age who wish to become pregnant and/or are unwilling to use contraceptive measures or who are pregnant.
- Recipients requiring ACE inhibitors or AII blockers for a cardiovascular indication (e.g. systolic dysfunction).
- Recipients who are > 55 years old and had a history of cardiovascular disease (coronary artery disease, stroke or peripheral vascular disease).
Location and Contact Information
Mike Mauer, MD 612 624-9444 mauer001@umn.edu
Minnesota
University of Minnesota, Minneapolis, Minnesota, 55455, United States; Recruiting
Mauer Mauer, MD 612-624-9444 mauer001@umn.edu
Hassan N Ibrahim, MD, MS, Principal Investigator
Mike s mauer, MD, Sub-Investigator
Hennepin County Medical Center, Minneapolis, Minnesota, 55415, United States; Recruiting
Kasiske Bert, MD 612-624-9444 kasis001@umn.edu
John R Silkensen, MD, Sub-Investigator
More Information
Record last reviewed: October 2004
Last Updated: October 14, 2004
Record first received: September 3, 2003
ClinicalTrials.gov Identifier: NCT00067990
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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