NL-OMON31753
Completed
Phase 4
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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- kidney transplant function
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 100
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: at least 18 years
- •Acceptable renal function (eGFR Nankivell \> 30 ml/min, proteinuria \< 1\.0 g/day)
- •3 \- 4 months post renal transplantation with non\-heart\-beating donor graft
Exclusion Criteria
- •Banff grade \> 2 acute or vascular rejection at any time during this transplant pre\-randomization
- •Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant)..
- •Evidence of active systemic or localized major infection.
- •Planned use of agents with a known interaction with any of the following: sirolimus or its derivatives, macrolide antibiotics, corticosteroids, tacrolimus, or IMPDH inhibitor.
- •Immunosuppressive therapies other than those described above
- •Subjects with a screening/baseline total white blood cell count \< 2,000/mm3 or ANC \< 1000, platelet count \< 100,000/mm3\.
- •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.
- •Subjects who are known to be HIV positive and/or subjects with active Hepatitis B or active Hepatitis C.
Outcomes
Primary Outcomes
Not specified
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