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Completed

NCT Number: NCT01028092

mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation

This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for elderly (>60 years old) recipients receiving graft from elderly donor(>60 years old).

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Key information

Conditions

Renal Transplant

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient who has given written informed consent to participate in the study
  • First or second single transplantation of a recipient (male or female) older than 60 years old
  • Donor older than 60 years old
  • PRA < 30%

Exclusion criteria

  • Living donor
  • Third transplantation
  • PRA > 30%

Other protocol-defined inclusion/exclusion criteria may apply.

  • Recipient of multi-organ transplant
  • Active major infections (HBV, HCV, HIV)
  • Loss of a first graft for immunologic issues
  • Anemia (<9g/l) or leucopenia (<2500/mm3)

Treatment and study plan

Anti R-IL2 + Cyclosporine

Drug
  • anti R-IL2 induction (Simulect ®, 20 mg D0 and D4)
  • Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0
  • cyclosporine A (Neoral ®) started from 6 to 8 mg/kg adjusted to C2
  • corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6

Thymoglobulin + Everolimus

Drug
  • Thymoglobulin ® induction started at 1.5mg/kg/j then adjusted to CD2 or total lymphocytes count, for 5 days
  • Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0
  • everolimus (Certican ®): 4 to 6 mg/day started at D5, adjusted to achieve a residual level between 6 et 10 ng/ml
  • corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6

Anti R-IL2 + Cyclosporine then Everolimus

Drug
  • anti R-IL2 induction (Simulect ®, 20 mg D0 and D4)
  • Mycophenolate Mofetil (Cellcept ®) 3 g/d beginning at D0
  • cyclosporine A (Neoral ®) beginning at 6 to 8 mg/kg adjusted to C2, then switch to everolimus (Certican ®) between at W6, started at 3 mg/d, then adjusted to achieve a residual level between 6 et 10 ng/ml
  • corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6

Primary outcomes

  1. calculated renal function with MDRD equation

    Time frame: 12 months

Secondary outcomes

  1. Acute rejection rate

    Time frame: 12 months

  2. Patient and graft survival rate

    Time frame: 12 months

  3. Adverse events

    Time frame: 12 months

  4. GFR calculated with Cockcroft Gault formula

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • Genzyme, a Sanofi Company
  • Ministry of Health, France
  • Novartis
  • Roche Pharma AG

Registry information

Acronym: EVEROLD

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Dec 9, 2009
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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