CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 153 enrolled
Drug / intervention
Losartan 100mg +1 moredrug
Likely dose
Losartan 100 mg orally once daily, started within three months of transplant and continued for five yearsAI-extracted
Key inclusion· 3
  • Age >18 years
  • First or second renal transplant alone or combined with pancreas transplantation
  • Adequate baseline biopsy with at least 10 cortical projection fields
Key exclusion· 10
  • Age <18 years
  • Serum creatinine ≥2.5 mg/dL
  • Persistent hyperkalemia (potassium >5.4 mEq/L)
  • Known hypersensitivity to losartan or iodine allergy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00067990
NCT00067990Phase 4Completed

Angiotensin II Blockade for the Prevention of Cortical Interstitial Expansion and Graft Loss in Kidney Transplant Recipients

University of Minnesota·interventional·Posted Sep 5, 2003·Updated Sep 18, 2017

In Brief

A Phase 4 clinical trial evaluating Losartan 100mg and Placebo for Kidney Disease and Proteinuria. Completed, enrolled 153 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2003
Enrollment StartDec 1, 2002
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 22.8 years ago

Interventions

Losartan 100mgdrug

To be started within three months of transplant and continued for five years.

Placebodrug

No treatment with continued follow-up for five years.