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

NCT01802268

Last updated date
Study Location
Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil
Curitiba, Paraná, , Brazil
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Transplant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients
Official Title  ICMJE Outcomes of Planned Conversion From Tacrolimus to Sirolimus-based Immunosuppressive Regimen in de Novo Kidney Transplant Recipients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Transplant
Intervention  ICMJE
  • Drug: Conversion from Tacrolimus to Sirolimus
  • Drug: Maintenance on tacrolimus
Study Arms  ICMJE
  • Active Comparator: Sirolimus
    Conversion from Tacrolimus to Sirolimus
    Intervention: Drug: Conversion from Tacrolimus to Sirolimus
  • Active Comparator: Tacrolimus
    Maintenance on tacrolimus
    Intervention: Drug: Maintenance on tacrolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2013)
320
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01802268
Other Study ID Numbers  ICMJE 0468E8-3328
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Helio Tedesco Silva Junior, Hospital do Rim e Hipertensão
Study Sponsor  ICMJE Helio Tedesco Silva Junior
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Helio T. Silva Junior, PhDNephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
Study Chair:Claudia R. Felipe, PhDNephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
Study Chair:Valter D. Garcia, PhDKidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil
Study Chair:Elias D. Neto, PhDRenal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil
Study Chair:Mario A. Filho, PhDInstituto de Urologia e Nefrologia & Medical School-FAMERP/HB-FUNFARME, São José do Rio Preto-SP, Brazil
Study Chair:Fabiana LC Cortieri, PhDHospital University Evangélico de Curitiba, Curitiba, Parana, Brazil
Study Chair:Deise BM Carvalho, PhDNephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil
Study Director:Jose OM Pestana, PhDNephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
PRS Account Hospital do Rim e Hipertensão
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP