NCT01744470

Efficacy and Safety Study of a 4-Month Post-Renal Transplant Dose Reduction of Tacrolimus(ADEQUATE)

Efficacy and Safety Outcome of Two Different Targets of Advagraf® Trough Levels Between 4 Months and 12 Months After Transplantation Among de Novo Renal Transplant Recipients.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This prospective, interventional, open label, randomized, multicenter study was designed to determine the risk/benefit ratio of a 50 % reduction of Advagraf® daily dose, 4 months after transplantation. Randomized patients are to be stable with their tacrolimus daily dose required to reach targeted tacrolimus trough levels. Based on Month-3 eligibility assessments, patients will be randomized in two groups (1:1): patients with 50 % reduction of the daily dose of Advagraf® 4 months after transplantation, and patients kept on their usual dose. The benefit/risk ratio will include the assessment of renal function, histological lesions from both alloreactivity and CNI nephrotoxicity, and safety data (metabolic and infectious diseases).

Conditions

• De Novo Transplant Disease

Interventions

Type	Name	Description
DRUG	Tacrolimus targeted half-dose
DRUG	Tacrolimus targeted plain dose

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2012-12-06
• Last updated: 2014-04-08

Locations

16 sites across 1 country: France