Efficacy of Certican® in Combination With Myfortic® in Renal (HUSJ1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Hospital Universitário São José.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hospital Universitário São José
ClinicalTrials.gov Identifier:
NCT01399242
First received: June 20, 2011
Last updated: July 20, 2011
Last verified: March 2011
  Purpose

The primary objective is to demonstrate the superiority of everolimus plus Myfortic® plus corticosteroids following CNI withdrawal at week 16 compared to tacrolimus plus Myfortic® plus corticosteroids as measured by the change in calculated Glomerular Filtration Rate (cGFR) from baseline to month 12.

The key secondary objective is to demonstrate non-inferiority of biopsy-proved acute rejection (BPAR), graft loss, death or loss to follow-up (composite endpoint) at month 12 in patients switched to everolimus plus Myfortic® plus corticosteroids following CNI withdrawal at Week 16 compared to patients maintained on tacrolimus plus Myfortic® plus corticosteroids.

Patients will be submitted to monthly GFR determination but, for group comparison, only the GFR measured at month 12 and month 24 of renal transplantation will be used.


Condition Intervention Phase
Disorder Related to Renal Transplantation
Drug: Certican
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Certican® in Combination With Myfortic® in Adult Renal Allograft Recipients Following Calcineurin Inhibitor Withdrawal at Week 16 Compared to Patients Who Are Maintained on Tacrolimus and Myfortic®

Resource links provided by NLM:


Further study details as provided by Hospital Universitário São José:

Primary Outcome Measures:
  • Glomerular Filtration Rate [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
    The primary objective is to demonstrate the superiority of everolimus plus Myfortic® plus corticosteroids following CNI withdrawal at week 16 compared to tacrolimus plus Myfortic® plus corticosteroids as measured by the change in calculated Glomerular Filtration Rate (cGFR) from baseline to month 12.


Secondary Outcome Measures:
  • Non-inferiority of biopsy-proved acute rejection (BPAR), graft loss, death [ Time Frame: 1 year after enrollment ] [ Designated as safety issue: Yes ]
    The key secondary objective is to demonstrate non-inferiority of biopsy-proved acute rejection (BPAR), graft loss, death or loss to follow-up (composite endpoint) at month 12 in patients switched to everolimus plus Myfortic® plus corticosteroids following CNI withdrawal at Week 16 compared to patients maintained on tacrolimus plus Myfortic® plus corticosteroids.


Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Certican, prednisona, EC-MPS
Twenty patients will be selected at 16 weeks of renal transplantation to convert a immunosuppression to certican,prednisone and myfortic. The allocation will be done randomly to provide similar epidemiological characteristics with respect to gender, age, renal function and co morbidities in the two groups. The informed consent will obtained after an interview involving the researcher and patient when the protocol will be explained.A protocol renal biopsy will be performed at the end of the study, 12 months after transplantation
Drug: Certican
Patients' therapy will be replaced from tacrolimus-based to everolimus-based immunosuppression. Everolimus will be introduced on day 1 at dose of 2 mg/day (1mg bid), and then everolimus trough levels will be obtained from day 3 onwards until C0 reaches the target for three consecutive days. Through levels will be adjusted to achieve 6-10ng/ml. Thereafter, if the target level was reached, the measurement will be performed weekly for 4 weeks and every 2 weeks until 8 weeks after conversion.In parallel, the tacrolimus dose will be reduced by 50% on day 1 and another 25% on day 7. The Tacrolimus will be withdrawn on day 14 if the target levels of everolimus are obtained.EC-MPS will be unchanged until day 14 after conversion.
Other Name: Myfortic, Prograf, Certican.
No Intervention: Tacrolimus,Prednisona, EC-MPS
Twenty patients will be selected at 16 weeks of renal transplant to continue use EC-MPS,Tacrolimus and Prednisone. The allocation will be done randomly to provide similar epidemiological characteristics with respect to gender, age, renal function and co morbidities in the two groups. The informed consent will obtained after an interview involving the researcher and patient when the protocol will be explained.A protocol renal biopsy will be performed at the end of the study, 12 months after transplantation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women between 18-70 years old
  • Receptors of a first living-donor kidney allograft
  • Patients must have been on a tacrolimus+myfortic regimen for at least 2 weeks prior to randomization

Exclusion Criteria:

  • Patients with evidence of any acute rejection following transplantation at the time of randomization
  • GFR ≤ 35 ml/min
  • Proteinuria > 800 mg/day
  • Recipients of multiple organ transplants
  • Chronic hepatic failure
  • Asymptomatic bacteriuria
  • Creatinine ≥ 2mg/dL on CNI withdrawn time
  • Proteinuria ≥ 1g/24h on CNI withdrawn time
  • Presence of uncontrolled hypercholesterolemia (≥ 350 mg/dL, ≥ 9.1 mmol/L)
  • Hypertriglyceridemia (≥ 500 mg/dL, ≥ 5.6 mmol/L)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399242

Contacts
Contact: Marcus F lasmar 55-31-83351036 marcuslasmar@hotmail.com
Contact: Luiz Flavio Giordano 55-31-91944606 luizgiordano@uol.com.br

Locations
Brazil
Hospital Universitário São José Not yet recruiting
Belo Horizonte, Minas Gerais, Brazil, 30140-073
Contact: Euler P Lasmar    55-31-92640096    eulerlasmar@superig.com.br   
Contact: Marcus F Lasmar    55-31-83351036    marcuslasmar@hotmail.com   
Principal Investigator: Euler P Lasmar         
Sponsors and Collaborators
Hospital Universitário São José
Investigators
Study Director: Euler P lasmar Hospital Universitário Sao José
  More Information

Publications:

Responsible Party: Euler Pace Lasmar, Hospital Universitário Sao Jose
ClinicalTrials.gov Identifier: NCT01399242     History of Changes
Other Study ID Numbers: EL-1254
Study First Received: June 20, 2011
Last Updated: July 20, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital Universitário São José:
Disorder Related to Renal Transplantation

Additional relevant MeSH terms:
Everolimus
Mycophenolate mofetil
Mycophenolic Acid
Sirolimus
Tacrolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014