Steroid free immunosuppression or calcineurin inhibitor minimization after Basiliximab induction therapy in kidney transplantation: Comparison with a standard quadruple immunosuppressive regimen.

Phase 4

Completed

Conditions: rejection
renal function
10038430

Registration Number: NL-OMON34397

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

Inclusion criteria
• Female or male, aged between 18 and 70 years.
• Recipient of a kidney graft (first or second) from a deceased (heartbeating or non-heartbeating) donor or living (non-HLA identical) donor.
• The patient understands the purpose and risks of the study and has given written informed consent to participate in the study.

Exclusion Criteria

Exclusion criteria
• Patients with multi-organ transplants
• Patients who are receiving a third or fourth transplant.
• Patients who have > 50 % (current or historic) panel reactive antibodies.
• Female patients who are pregnant or unwilling to use adequate contraception during the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary end-points<br /><br>Renal function parameters, proteinuria and microalbuminuria measured 3, 12 and<br /><br>24 months after transplantation. Renal function measured by endogenous<br /><br>creatinine clearances, serum creatinine and Nankivell GFR.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary end-points<br /><br>• Rejection episodes<br /><br>• Graft and patient survival<br /><br>• The degree of tubular atrophy and interstial fibrosis, inflammation plus the<br /><br>degree of arteriolar hyalinosis in renal biopsies taken at 12 and 24 months<br /><br>after transplantation. Biopsies will be evaluated according to the Banff *07<br /><br>Criteria for Renal Allograft Biopsy Interpretation (appendix II). Quantitative<br /><br>morphometric analysis of interstitial fibrous tissue will be performed using<br /><br>the digital image analysis technique.<br /><br>• Cardiovascular incidents, pulse wave velocity measurements and AGEs skin<br /><br>• Blood pressure (mean of three automated measurements while sitting up) and<br /><br>the number of antihypertensives<br /><br>• Lipid profile<br /><br>• The incidence of malignancies<br /><br>• Infectious complications<br /><br>• Dexa bone densitometry<br /><br>• Miscellaneous; Fasting glucose, oral glucose tolerance, HbA1c, uric acid<br /><br></p><br>