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

NCT00138970 | Completed Phase 4

• 1 other identifier: CLARIFI
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Renal Transplant Recipients

Keywords

Cadaveric donor; Calcineurine free

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• • 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.

Interventions

Zenapax®, CellCept® and prednisolone DRUG

Sandimmun Neoral®, CellCept® and prednisolone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.
• \. 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.
• \. Patients who are pregnant or nursing mothers. 9. Patients with ongoing malignancies, excluding adequately treated skin carcinoma.
• \. Patients not able to adhere to the investigational immunosuppressive therapy.
• \. Patients receiving bile-acid sequestants.

Sponsors & Collaborators

• University of Oslo School of Pharmacy: lead

MeSH Terms

Interventions

Daclizumab; Mycophenolic Acid; Prednisolone; Cyclosporine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Peptides

Study Officials

• Anders Hartmann, MD

  Rikshospitalet, Section of Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 30, 2005
• Study Start: January 1, 2002
• Study Completion: February 1, 2005
• Last Updated: December 1, 2005

Record last verified: 2005-08