Calcineurin Free Immunosuppression in Renal Transplant Recipients

NCT00812123

Last updated date
Study Location
University Hospital Basel, Clinic for Transplantation Immunology and Nephrology
Basel, , 4031, Switzerland
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Transplantation, Chronic Kidney Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
15-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


- 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.

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Kidney Transplantation, Chronic Kidney DiseaseCalcineurin Free Immunosuppression in Renal Transplant Recipients
NCT00812123
  1. Basel,
ALL GENDERS
15 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Calcineurin Free Immunosuppression in Renal Transplant Recipients
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
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 Transplantation
  • Chronic Kidney Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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. doi: 10.1053/j.ajkd.2009.09.004. Epub 2009 Nov 17.

*   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: December 18, 2008)
127
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2005
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 15 Years to 75 Years   (Child, 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 Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00812123
Other Study ID Numbers  ICMJE Calfree
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. J. Steiger, University Hospital Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Jürg U Steiger, MDClinic for Transplantation Immunology and Nephrology, University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date December 2008

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