A multi-center, randomized, controlled trial with programmed introduction of Sirolimus-based, Calcineurin inhibitor free immunosuppression in recipients of non-heart-beating donor kidney grafts. - PRINS study

• Conditions: Recipients of a renal allograft from a non-heart-beating donor, three months after transplantation.; MedDRA version: 9.1Level: LLTClassification code 10023438Term: Kidney transplant

• Registration Number: EUCTR2007-002763-27-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Age = 18 years.
2.Acceptable renal function (eGFR Nankivell > 30ml, Proteinuria < 1.0 g/day)
3.3-4 months post renal transplantation with a NHBD graft

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Banff grade > 2 acute or vascular rejection at any time during this transplant pre-randomization
2.Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant)..
3.Evidence of active systemic or localized major infection.
4.Use of any investigational drug or treatment up to 4 weeks prior to transplantation.
5.Planned use of agents with a known interaction with any of the following: sirolimus or its derivatives, macrolide antibiotics, corticosteroids, tacrolimus, or IMPDH inhibitor.
6.Immunosuppressive therapies other than those described above
7.Planned treatment with voriconazole, cisapride, or ketoconazole, that will not be discontinued prior to randomization.
8.Treatment with aminoglycosides, amphotericin B, cisplatin, or other drugs associated with renal dysfunction that is not discontinued prior to enrolment.
9.Subjects with a screening/baseline total white blood cell count < 2,000/mm3 or ANC < 1000, platelet count < 100,000/mm3.
10. Fasting triglycerides > 400 mg/dL (> 4.5 mmol/L) or fasting total cholesterol > 300 mg/dL (> 7.8 mmol/L) despite optimal lipid-lowering therapy.
11.Subjects who are known to be HIV positive and/or subjects with active Hepatitis B or active Hepatitis C.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the safety and efficacy of a programmed introduction of a Sirolimus-based, Calcineurin inhibitor free, maintenance immunosuppressive regime, three months after renal transplantation in recipients of a non-heart-beating donor kidney graft on: graft function as determined by eGFR and biopsy proven acute rejection rates at twelve months post randomization to programmed Sirolimus introduction<br>;Secondary Objective: Graft and patient survival. Infection rate. Malignancy rate. Dyslipidaemia. Proteinuria rate. Change in selectivity index of proteinuria. Blood pressure. Number of antihypertensive drugs. Cardiovascular event rate.;Primary end point(s): eGFR as determined by Nankivell at month 12 post randomization