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

NCT01802268 | Completed Phase 4 DMC

• 1 other identifier: 0468E8-3328
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 6

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.

Conditions

Kidney Transplant

Keywords

sirolimus; tacrolimus; early conversion

Outcome Measures

Primary Outcomes (1)

• Renal Function calculated using the 4 variable MDRD formula

  24 months

Secondary Outcomes (6)

• 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

Study Arms (2)

Sirolimus

ACTIVE COMPARATOR

Conversion from Tacrolimus to Sirolimus

Drug: Conversion from Tacrolimus to Sirolimus

Tacrolimus

ACTIVE COMPARATOR

Maintenance on tacrolimus

Drug: Maintenance on tacrolimus

Interventions

Conversion from Tacrolimus to Sirolimus DRUG

Sirolimus

Maintenance on tacrolimus DRUG

Tacrolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helio Tedesco Silva Junior: lead
• Pfizer: collaborator

Study Sites (6)

Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil

Curitiba, Paraná, Brazil

Location

Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Location

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

São Jose Do Rio Preto, São Paulo, 04038, Brazil

Location

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

São Paulo, São Paulo, 04038, Brazil

Location

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

São Paulo, São Paulo, 04038, Brazil

Location

Study Officials

• Helio T. Silva Junior, PhD

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

  PRINCIPAL INVESTIGATOR

• Claudia R. Felipe, PhD

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

  STUDY CHAIR

• Valter D. Garcia, PhD

  Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil

  STUDY CHAIR

• Elias D. Neto, PhD

  Renal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil

  STUDY CHAIR

• Mario A. Filho, PhD

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

  STUDY CHAIR

• Fabiana LC Cortieri, PhD

  Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil

  STUDY CHAIR

• Deise BM Carvalho, PhD

  Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil

  STUDY CHAIR

• Jose OM Pestana, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: March 1, 2013
• Study Start: February 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 1, 2013

Record last verified: 2013-02

Locations

BR (6)