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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2005-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Renal Transplant Recipients

Keywords

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Cadaveric donor Calcineurine free

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Zenapax®, CellCept® and prednisolone

Intervention Type DRUG

Sandimmun Neoral®, CellCept® and prednisolone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Anders Hartmann, MD

Role: PRINCIPAL_INVESTIGATOR

Rikshospitalet, Section of Nephrology

Other Identifiers

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CLARIFI

Identifier Type: -

Identifier Source: org_study_id