Status:
COMPLETED
Calcineurin Inhibitor-Free Immunosuppression in Renal Transplant Recipients at Low Immunogenic Risk
Lead Sponsor:
University of Oslo School of Pharmacy
Conditions:
Renal Transplant Recipients
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 immunosuppress...
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, receiv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00138970
Start Date
January 1 2002
End Date
February 1 2005
Last Update
December 1 2005
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