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

Sponsor

Helio Tedesco Silva Junior (Other)

Overall Status

Completed

CT.gov ID

NCT01802268

Collaborator

Pfizer (Industry)

320

Enrollment

Locations

Arms

Duration (Months)

53.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Outcomes of Planned Conversion From Tacrolimus to Sirolimus-based Immunosuppressive Regimen in de Novo Kidney Transplant Recipients

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sirolimus Conversion from Tacrolimus to Sirolimus	Drug: Conversion from Tacrolimus to Sirolimus
Active Comparator: Tacrolimus Maintenance on tacrolimus	Drug: Maintenance on tacrolimus

Arm

Intervention/Treatment

Active Comparator: Sirolimus

Conversion from Tacrolimus to Sirolimus

Drug: Conversion from Tacrolimus to Sirolimus

Active Comparator: Tacrolimus

Maintenance on tacrolimus

Drug: Maintenance on tacrolimus

Outcome Measures

Primary Outcome Measures

Renal Function calculated using the 4 variable MDRD formula [24 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil	Curitiba	Paraná	Brazil
2	Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil	Porto Alegre	Rio Grande do Sul	Brazil
3	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
4	Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil	Rio de Janeiro		Brazil
5	Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil	São Paulo		Brazil	04038
6	Renal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, 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