Calcineurin Free Immunosuppression in Renal Transplant Recipients

December 18, 2008 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

127

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel, Clinic for Transplantation Immunology and Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 71 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcineurin free
Immunosuppression with Sirolimus, Mycophenolate and Steroids
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 Names:
  • Rapamune
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 Names:
  • CellCept
Procedure: Protocol biopsies
protocol kidney biopsies at month one and three
Active Comparator: Calcineurin
Immunosuppressive therapy with Cyclosporin A, Mycophenolate and Steroids
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 Names:
  • CellCept
Procedure: Protocol biopsies
protocol kidney biopsies at month one and three
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 Names:
  • Sandimmun neoral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma Creatinine
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Graft survival
Time Frame: 6 months
6 months
Patient survival
Time Frame: 6 months
6 months
Incidence of first acute rejections and number of total rejections
Time Frame: 6 months
6 months
Total number of anti-rejection treatments
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Jürg U Steiger, MD, Clinic for Transplantation Immunology and Nephrology, University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 18, 2008

First Posted (Estimate)

December 19, 2008

Study Record Updates

Last Update Posted (Estimate)

December 19, 2008

Last Update Submitted That Met QC Criteria

December 18, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Calfree

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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