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Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)

NCT01950819 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2037

Last updated 2019-01-30

Study results available
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Summary

This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.

Conditions

  • End Stage Renal Disease (ESRD)
  • Chronic Kidney Disease (CKD)
  • Hemodialysis
  • Renal Replacement Therapy
  • Renal Transplantation

Interventions

BIOLOGICAL

Induction therapy

All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.

DRUG

Corticosteroids

All subjects received maintenance therapy with corticosteroids throughout the 24 month study period. A minimum dose of 5 mg prednisone, or equivalent, per day was maintained.

DRUG

EVR+rCNI

Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)

DRUG

MPA+sCNI

Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-03
Primary Completion
2017-02-01
Completion
2018-01-17

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Chile
  • Colombia
  • Croatia
  • Czechia
  • Egypt
  • France
  • Germany
  • Greece
  • India
  • Israel
  • Italy
  • Japan
  • Kuwait
  • Lebanon
  • Malaysia
  • Mexico
  • Netherlands
  • Norway
  • Philippines
  • Poland
  • Portugal
  • Russia
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01950819 on ClinicalTrials.gov