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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Helio Tedesco Silva Junior, Hospital do Rim e Hipertensão
ClinicalTrials.gov Identifier:
NCT01802268
First received: February 22, 2013
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Kidney Transplant
Drug: Conversion from Tacrolimus to Sirolimus
Drug: Maintenance on tacrolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outcomes of Planned Conversion From Tacrolimus to Sirolimus-based Immunosuppressive Regimen in de Novo Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Hospital do Rim e Hipertensão:

Primary Outcome Measures:
  • Renal Function calculated using the 4 variable MDRD formula [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival free from first treated biopsy confirmed acute rejection episodes (tBCAR) > IA according to Banff 1997 classification. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Incidence of all treated acute rejections. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Incidence and severity of all tBCAR. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Patient and graft survival. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Incidence of treatment discontinuation [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 320
Study Start Date: February 2008
Study Completion Date: October 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sirolimus
Conversion from Tacrolimus to Sirolimus
Drug: Conversion from Tacrolimus to Sirolimus
Active Comparator: Tacrolimus
Maintenance on tacrolimus
Drug: Maintenance on tacrolimus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802268

Locations
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
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, 04038
Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil
Rio de Janeiro, Brazil
Renal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.
São Paulo, Brazil, 04038
Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
São Paulo, Brazil, 04038
Sponsors and Collaborators
Helio Tedesco Silva Junior
Pfizer
Investigators
Principal Investigator: Helio T. Silva Junior, PhD Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
Study Chair: 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 Director: Jose OM Pestana, PhD Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
  More Information

No publications provided

Responsible Party: Helio Tedesco Silva Junior, PhD, Hospital do Rim e Hipertensão
ClinicalTrials.gov Identifier: NCT01802268     History of Changes
Other Study ID Numbers: 0468E8-3328
Study First Received: February 22, 2013
Last Updated: February 27, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital do Rim e Hipertensão:
sirolimus
tacrolimus
early conversion

Additional relevant MeSH terms:
Sirolimus
Everolimus
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 15, 2014