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)

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) - TRANSFORM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44739

Enrollment

130

Registered

2013-11-13

Start date

2014-03-18

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

niertransplantatie rejection after kidney transplantation

Interventions

Treatment with everolimus plus low dose Tacrolimus or Cyclosporine or treatment with Mycophenolic acid plus standard dose Tacrolimus or Cyclosporine.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Male and female patients, * 18 years of age. * Randomized within 24 hr of completion of transplant surgery. * Cold ischemia time

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Treated biopsy-proven acute rejection (tBPAR), eGFR	—

Secondary

Measure	Time frame
Efficacy failure rate (tBPAR, graft loss or death).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)