Calcineurin Free Immunosuppression in Renal Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Wyeth Pharmaceuticals AG, Switzerland
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00812123
First received: December 18, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted

December 18, 2008
December 18, 2008
January 2001
July 2005   (final data collection date for primary outcome measure)
Plasma Creatinine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Graft survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of first acute rejections and number of total rejections [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Total number of anti-rejection treatments [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Calcineurin Free Immunosuppression in Renal Transplant Recipients
Open, Single Center, Randomised, Parallel Group Pilot Study to Investigate a Calcineurin Free Immunosuppressive Treatment for de Novo Renal Transplant Recipients: A Comparison of a Rapamycin/MMF/Steroids Regime to a Cyclosporine A Neoral/MMF/Steroids Regimen in the Prevention of Acute Rejection Following Renal Transplantation

The main purpose of this study is to obtain preliminary information on the efficacy, safety and cost of two regimens, Rapamycin / MMF / steroid therapy and Cyclosporine A Neoral / MMF / steroid therapy, used in the prevention of acute rejection following renal transplantation.

This pilot study is designed to show differences in efficacy, safety and cost between the two regimens. Its main purpose is to provide information, if calcineurin free immunosuppressive treatment is a valuable alternative in the treatment of de novo kidney transplant recipients. Furthermore, by investigating the side effects in both arms it will be possible to decide, if the absence of calcineurin inhibition and lack of nephrotoxicity will outweigh the adverse effects of Rapamycin. With the obtained information it will be possible to plan a larger trial, which is warranted to compare the mentioned treatment regimens in more detail.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Kidney Transplantation
  • Chronic Kidney Disease
  • Drug: Sirolimus
    Loading dose 30 mg for three days, trough level of 10-20 ng/ml month 1-3, 8-15 ng/ml month 4 - 6
    Other Name: Rapamune
  • Drug: Cyclosporine A
    Loading dose of 300 mg for three days, trough levels 250-300 ng/ml months 1-3, 150-250 ng/ml months 4 to 6
    Other Name: Sandimmun neoral
  • Drug: Prednisone
    0.5 mg/kg, tapering every two weeks until 0.1 mg/kg
  • Drug: Mycophenolate mofetil
    2 x 1000mg, through level above 2ug/ml
    Other Name: CellCept
  • Procedure: Protocol biopsies
    protocol kidney biopsies at month one and three
  • Experimental: Calcineurin free
    Immunosuppression with Sirolimus, Mycophenolate and Steroids
    Interventions:
    • Drug: Sirolimus
    • Drug: Prednisone
    • Drug: Mycophenolate mofetil
    • Procedure: Protocol biopsies
  • Active Comparator: Calcineurin
    Immunosuppressive therapy with Cyclosporin A, Mycophenolate and Steroids
    Interventions:
    • Drug: Cyclosporine A
    • Drug: Prednisone
    • Drug: Mycophenolate mofetil
    • Procedure: Protocol biopsies
Franz S, Regeniter A, Hopfer H, Mihatsch M, Dickenmann M. Tubular toxicity in sirolimus- and cyclosporine-based transplant immunosuppression strategies: an ancillary study from a randomized controlled trial. Am J Kidney Dis. 2010 Feb;55(2):335-43. Epub 2009 Nov 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
July 2005
July 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patients between 15 and 75 years of age, regardless of race.
  • Female patients of child bearing age agree to maintain effective birth control practice during the study.
  • Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation as assessed by the transplantation center.
  • Patient has been fully informed and has given written or independent person witnessed oral informed consent.

Exclusion Criteria:

  • Patient is pregnant or breastfeeding.
  • Patient has a low immunological risk constellation, defined by receiving a kidney from a HLA-identical related living donor.
  • Patient has a high immunological risk constellation, defined as having within the previous three years a measured PRA grade of ≥25% and/or having a previous graft survival shorter than 3 years due to rejection.
  • Patient and donor have a positive T or B-cell crossmatch.
  • Patient and donor are ABO incompatible.
  • Age of donor > 68 years.
  • Cold ischemia time > 36 hours.
  • Patient has leucopenia, defined as having at transplantation less than 3000/mm3 leukocytes.
  • Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3 thrombocytes.
  • Patient is allergic or intolerant to cremophor RH 60 or structurally related compounds, steroids, Cyclosporine A Neoral, Rapamycin or MMF.
  • Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s).
  • Patient or donor is known to be HIV positive.
  • Patient has significant liver disease, defined as having during the past 28 days continuously ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 fold of the upper value of the normal range of the investigational site.
  • Patient with malignancy or history of malignancy ≥ 2 years, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
  • Patient has significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer.
  • Patient is taking or has been taking an investigational drug in the past 28 days.
  • Patient has previously received or is receiving another organ transplant other than kidney.
  • Patient is unlikely to comply with the visits schedule in the protocol.
Both
15 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00812123
Calfree
No
Prof. Dr. J. Steiger, University Hospital Basel, Switzerland
University Hospital, Basel, Switzerland
Wyeth Pharmaceuticals AG, Switzerland
Principal Investigator: Jürg U Steiger, MD Clinic for Transplantation Immunology and Nephrology, University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
December 2008

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