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Calcineurin Inhibitor-Free Immunosuppression in Renal Transplant Recipients at Low Immunogenic Risk

This study has been completed.
Sponsor:
Information provided by:
University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:
NCT00138970
First received: August 29, 2005
Last updated: November 30, 2005
Last verified: August 2005
  Purpose

To compare renal function (51Cr-EDTA clearance) 12 months posttransplant, in primary renal allograft recipients (from cadaveric donor) at low immunogenic risk, 0 DR mis-match, receiving immunosuppressive therapy with A) Zenapax® (5 doses), CellCept® (1.5 g bid., aiming for TDM for total trough concentrations of 2-6 mg/L) and prednisolone or B) Sandimmun Neoral® (full dose), CellCept® (1.0 g bid.) and prednisolone.


Condition Intervention Phase
Renal Transplant Recipients
Drug: Zenapax®, CellCept® and prednisolone
Drug: Sandimmun Neoral®, CellCept® and prednisolone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomised, Double-Arm, Controlled, Open-Label Study Comparing Calcineurin Inhibitor-Free Immunosuppression (Zenapax®, CellCept® and Prednisolone) and Cyclosporine A Based Immunosuppression (Sandimmun Neoral®, CellCept® and Prednisolone) on the Outcome of Renal Function and Acute Rejection in 0 DR Mis-Matched Renal Allograft Recipients

Resource links provided by NLM:


Further study details as provided by University of Oslo School of Pharmacy:

Primary Outcome Measures:
  • The primary efficacy endpoint is the renal function, evaluated by 51Cr-EDTA clearance and normalized for 1.73 m2 body-surface, at 12 months posttransplant.

Secondary Outcome Measures:
  • • Combined patient and graft survival at 12 months posttransplant.
  • • Proportion of patients with biopsy-proven acute rejection or acute rejection (biopsy proven + presumptive) episode at 3 and 12 month posttransplant.
  • • Incidence and severity of hypertension at 10 weeks and 12 months posttransplant.
  • • Incidence and severity of dyslipidemia at 10 weeks and 12 months posttransplant.
  • • Incidence of glucose intolerance at 10 weeks and 12 months posttransplant.
  • • Incidence of treatment failure at 12 months posttransplant.
  • • Success rate of TDM guided CellCept® dosing at 3 months posttransplant.
  • • Infection rate.

Estimated Enrollment: 70
Study Start Date: January 2002
Estimated Study Completion Date: February 2005
Detailed Description:

Primary Objective To compare renal function (51Cr-EDTA clearance) 12 months posttransplant, in primary renal allograft recipients (from cadaveric donor) at low immunogenic risk, 0 DR mis-match, receiving immunosuppressive therapy with A) Zenapax® (5 doses), CellCept® (1.5 g bid., aiming for TDM for total trough concentrations of 2-6 mg/L) and prednisolone or B) Sandimmun Neoral® (full dose), CellCept® (1.0 g bid.) and prednisolone.

Secondary Objectives To compare the two treatment groups with regard to: patient and graft survival (12 months), biopsy-proven and presumptive rejection episodes (3 and 12 months), posttransplant (12 months) incidence and severity of hypertension, hyperlipidemia, glucose intolerance, incidence of infection and tolerability and “success rate” of TDM guided CellCept® dosing in a calcineurin inhibitor-free immunosuppressive protocol over 12 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Patients of either gender above 18 years of age. 2. Patients who are recipients of primary, 0 DR mis-matched renal allografts from cadaveric donors (aged between 10 and 70 years).

    3. Patients who are single organ recipients (kidney only). 4. If the patients are women of childbearing potential, they must use safe contraceptives.

    5. Patients not previously treated with Zenapax® or Simulect®. 6. Patients must be capable to understand the information given about the study, including purpose and risks, and they must sign a statement of informed consent in accordance with the Helsinki declaration.

    7. Patients with white blood count greater than 2.5 x 109 /L (IU), platelet count greater than 100 x 109 /L (IU) or haemoglobin greater than 6 g/dL at the time of entry into the study.

Exclusion Criteria:

  • 1. Patients who are recipients of HLA-identical renal transplants. 2. PRA positive (>20%) patients at any time the alst 6 months. 3. Patients who are unable to stay outside hospital as outpatients for 3 months.

    4. Patients who are unable to receive oral medication. 5. Patients with active peptic ulcer disease. 6. Patients with active infection. 7. Patients with disorders which might interfere with their ability to absorb oral medication, such as severe diarrhoea or patients with previously diagnosed diabetic gastroenteropathy.

    8. Patients who are pregnant or nursing mothers. 9. Patients with ongoing malignancies, excluding adequately treated skin carcinoma.

    10. Patients not able to adhere to the investigational immunosuppressive therapy.

    11. Patients receiving bile-acid sequestants.

  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: NCT00138970

Sponsors and Collaborators
University of Oslo School of Pharmacy
Investigators
Principal Investigator: Anders Hartmann, MD Rikshospitalet, Section of Nephrology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00138970     History of Changes
Other Study ID Numbers: CLARIFI
Study First Received: August 29, 2005
Last Updated: November 30, 2005
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by University of Oslo School of Pharmacy:
Cadaveric donor
Calcineurine free

Additional relevant MeSH terms:
Cyclosporine
Cyclosporins
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Mycophenolate mofetil
Mycophenolic Acid
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Infective Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antifungal Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on November 19, 2014