A 24 month, multicenter, randomized, open-label safety and efficacy study of concentration-controlled everolimus with reduced calcineurin inhibitor vs mycophenolate with standard calcineurin inhibitor in de novo renal transplantation- Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen (TRANSFORM)

Phase 4

Completed

• Conditions: niertransplantatie; rejection after kidney transplantation; 10038430

• Registration Number: NL-OMON44739
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

* Male and female patients, * 18 years of age.
* Randomized within 24 hr of completion of transplant surgery.
* Cold ischemia time < 30 hr.
* Primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased heart beating, living unrelated, living related non-human leukocyte antigen identical or an expanded criteria donor.

Exclusion Criteria

* Multi-organ transplant recipient.
* High immunological risk for rejection.
* BMI >35.
* Severe systemic infections, current or within the two weeks prior to randomization.
* Systemic anticoagulation that cannot be temporarily interrupted and which would preclude renal biopsy.
* Pregnant or lactating women.
* Women of child-bearing potential not using adequate contraception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Treated biopsy-proven acute rejection (tBPAR), eGFR < 50 mL/min/1.73m2 at Month<br /><br>12 post-transplantation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Efficacy failure rate (tBPAR, graft loss or death).</p><br>