Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients

Phase 4

Completed

• Conditions: Kidney Transplant
• Interventions: Drug: Conversion from Tacrolimus to Sirolimus; Drug: Maintenance on tacrolimus

• Registration Number: NCT01802268
• Lead Sponsor: Helio Tedesco Silva Junior

Brief Summary

Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate long-term CNi associated adverse events. This study aims to evaluate the conversion from tacrolimus to sirolimus in de novo kidney transplant recipients.

This multicenter, open-label study, planned to enroll 297 patients initially treated with tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The primary objective is to show superior glomerular filtration rate in the SRL group at 24 months after transplantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2012-04
• Study Completion: 2012-10
• Status Verified: 2013-02
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-02-27
• Last Update Submitted: 2013-02-27
• Study First Posted: 2013-03-01
• Last Update Posted: 2013-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• patients older than 18 years,
• recipients of first kidney transplant from brain dead deceased or living related non-HLA identical donors not older than 65 years,
• patients had to receive an ABO compatible organ with a CDC negative crossmatch and a peak panel reactive antibody lower that 30%,
• all patients agreed to use contraceptive methods during the study and up to 3 months after study drug discontinuation.

Exclusion Criteria

• patients with chronic kidney diseases due to focal and segmental glomerulosclerosis and membranoproliferative glomerulonephritis,
• patients with active infection or positive for hepatitis B or C or human immunodeficiency viruses,
• patients with previous history of malignancy,
• patients with significant hematological or metabolic laboratorial abnormalities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sirolimus	Conversion from Tacrolimus to Sirolimus	Conversion from Tacrolimus to Sirolimus
Tacrolimus	Maintenance on tacrolimus	Maintenance on tacrolimus

Primary Outcome Measures

Name	Time	Method
Renal Function calculated using the 4 variable MDRD formula	24 months

Secondary Outcome Measures

Name	Time	Method
Survival free from first treated biopsy confirmed acute rejection episodes (tBCAR) > IA according to Banff 1997 classification.	24 months
Incidence of all treated acute rejections.	24 months
Incidence and severity of all tBCAR.	24 months
Patient and graft survival.	24 months
Incidence of treatment discontinuation	24 months
Incidence of adverse events.	24 months

Trial Locations

Locations (6)

Instituto de Urologia e Nefrologia & Medical School-FAMERP/HB-FUNFARME, São José do Rio Preto-SP, Brazil; 🇧🇷 São Jose do Rio Preto, São Paulo, Brazil

Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil; 🇧🇷 São Paulo, Brazil

Renal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.; 🇧🇷 São Paulo, Brazil

Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil; 🇧🇷 Rio de Janeiro, Brazil

Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil; 🇧🇷 Curitiba, Paraná, Brazil

Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil