Phase 4
N=153
Angiotensin II Blockade for Chronic Allograft Nephropathy
Kidney Disease · Proteinuria
Bottom Line
View on ClinicalTrials.gov: NCT00067990 ↗Enrolled (actual)
153
Serious AEs
100.0%
Results posted
Sep 2017
Primary outcome: Primary: Doubling of Interstitium or Any ESRD — 6; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Losartan 100mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Doubling of Interstitium or Any ESRD |
6; 12 | — |
| SECONDARY Number of Participants With Cortical Interstitial Volume Expansion or Any ESRD |
7; 15 | — |
Summary
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.
Eligibility 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 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).
Data sourced from ClinicalTrials.gov (NCT00067990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.