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

Kidney Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802268
• Other study ID #: 0468E8-3328
• Status: Completed
• Phase: Phase 4
• First received: February 22, 2013
• Last updated: February 27, 2013
• Start date: February 2008
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Hospital do Rim e Hipertensão
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: October 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Drug:
• Conversion from Tacrolimus to Sirolimus

• Maintenance on tacrolimus

Locations

Country	Name	City	State
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	Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil	Rio de Janeiro
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	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

Sponsors (2)

Lead Sponsor	Collaborator
Helio Tedesco Silva Junior	Pfizer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal Function calculated using the 4 variable MDRD formula		24 months	No
Secondary	Survival free from first treated biopsy confirmed acute rejection episodes (tBCAR) > IA according to Banff 1997 classification.		24 months	No
Secondary	Incidence of all treated acute rejections.		24 months	No
Secondary	Incidence and severity of all tBCAR.		24 months	No
Secondary	Patient and graft survival.		24 months	Yes
Secondary	Incidence of treatment discontinuation		24 months	Yes
Secondary	Incidence of adverse events.		24 months	Yes