Calcineurin Free Immunosuppression in Renal Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
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
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Chronic Kidney Disease
Drug: Sirolimus
Drug: Cyclosporine A
Drug: Prednisone
Drug: Mycophenolate mofetil
Procedure: Protocol biopsies
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Plasma Creatinine [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 127
Study Start Date: January 2001
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: CellCept
Procedure: Protocol biopsies
protocol kidney biopsies at month one and three
Active Comparator: Calcineurin
Immunosuppressive therapy with Cyclosporin A, Mycophenolate and Steroids
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00812123

Locations
Switzerland
University Hospital Basel, Clinic for Transplantation Immunology and Nephrology
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
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
  More Information

No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. J. Steiger, University Hospital Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00812123     History of Changes
Other Study ID Numbers: Calfree
Study First Received: December 18, 2008
Last Updated: December 18, 2008
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
kidney transplantation
calcineurin inhibitor free
protocol biopsy
Cyclosporin A
Sirolimus

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Cyclosporins
Cyclosporine
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Sirolimus
Everolimus
Prednisone
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on August 21, 2014