NCT00933231

Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts

A Comparison of Effects of Standard Dose vs. Low Dose Advagraf® With IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without ACEi/ARB - Based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune Response

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre study examining the use of Advagraf-minimization strategy and/or the use of an inhibitor of the renin-angiotensin system in reducing chronic rejection in renal allografts.

Detailed description

The study will consist of the following 4 treatment groups.: 1. Standard dose Advagraf with angiotensin-converting enzyme inhibitor (ACEi)/angiotensin receptor blocker (ARB) antihypertensive therapy 2. Standard dose Advagraf without ACEi/ARB antihypertensive therapy 3. Low dose Advagraf with ACEi/ARB antihypertensive therapy 4. Low dose Advagraf without ACEi/ARB antihypertensive therapy

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	tacrolimus	Standard dose, Oral
DRUG	tacrolimus	Low dose, Oral
BIOLOGICAL	Simulect	IV
DRUG	Cellcept	Oral
DRUG	Corticosteroids	IV and Oral
DRUG	Ramipril	Oral
DRUG	Irbesartan	Oral

Timeline

• Start date: 2009-08-17
• Primary completion: 2015-05-11
• Completion: 2018-04-03
• First posted: 2009-07-07
• Last updated: 2024-11-01

Locations

13 sites across 1 country: Canada