A twelve-month, multicenter, open-label, randomized study of the safety, tolerability and efficacy of Certican* with Simulect, corticosteroids and two different exposure levels of tacrolimus in de novo renal transplant recipients

Phase 4

Completed

• Conditions: transplantatie geneeskunde; renal transplantation; 10038430

• Registration Number: NL-OMON30348
• Lead Sponsor: PPD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

Male or female 18-65 years old
Primary transplant from cadaveric, living-unrelated or non-HLA identical living related donor
Cold Ischemia time <30 h
Negative pregnancy test in female
Willing and capable to give written informed consent

Exclusion Criteria

Multiple organtransplants
Non-heart beating donor
PRA>=50%
Hypercholestrolemia >9,1 mmol/L
Leucocytes <3
HIV, HBSag or anti HBC AB positive
Allergy to one of the drugs
Malignancy apart from localised skin tumors
Unable to cooperate or communicate with the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This objective will be assessed by comparing renal function evaluated by<br /><br>calculated glomerular filtration rate (MDRD formula) at 12 months<br /><br>post-transplant (this method has gained favor in the transplant literature<br /><br>above the endogenous creatinine clearance because its reproducibility is far<br /><br>greater).</p><br>