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Impact of Cyclosporine or Steroid Withdrawal at 3 Months Post Transplantation on Graft Function, Patient Survival and Cardiovascular Surrogate Markers the First 5 Years After Renal Transplantation.


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Renal Transplantation

Thank you

Trial Information

Impact of Cyclosporine or Steroid Withdrawal at 3 Months Post Transplantation on Graft Function, Patient Survival and Cardiovascular Surrogate Markers the First 5 Years After Renal Transplantation.


Methodology:

- A 5-year, multicentre, prospective, randomized, open-label, controlled study

- Group 1: Simulect + cyclosporine + Myfortic + steroid stop at 3 months

- Group 2: Simulect + cyclosporine (decrease dose in one week at month 3 and replace
by everolimus) + Myfortic + steroid maintenance.

- In both groups MPA AUC monitoring will be done at 5-7 days and at 3 months, to ensure
sufficient MPA protection.

Sample size calculations:

A total of 152 patients will be randomized (76 patients per group)

Population:

De novo kidney transplant recipients.

Study duration:

1.5 years inclusion+ follow-up during the first 5 years


Inclusion Criteria:



- Male or female recipients of a de novo kidney transplant, aged above 18 years

- Women of childbearing potential must have a negative serum or urine pregnancy test
with sensitivity equal to at least 50 mIU/ml

- Patients must be capable of understanding the purpose and risks of the study, and
must sign an informed consent form

Exclusion Criteria:

- Multiple organ transplantation (e.g., Kidney-pancreas, kidney-heart, kidney-
liver,...)

- Transplantation of a patient who got another organ transplant previously

- Recipients of a HLA-identical living-related renal transplant

- Patients with PRA > 30%, patients who have lost a first graft from rejection within
two years after transplantation, and African European patients.

- Patients with primary renal disease at risk for recurrence: FSGS, MPGN, HUS

- Pregnant or lactating women

- WBC < 2.5 x 109/l (IU), platelet count < 100 x 109/l (IU), or Hb < 6 g/dl at the time
of entry into the study

- Active peptic ulcer

- Severe diarrhea or other gastrointestinal disorder, which might interfere with their
ability to absorb oral medication, including diabetic patients with previously
diagnosed diabetic gastroenteropathy

- Known HIV-1 or HTLV-1 positive tests

- The use of investigational drugs or other immunosuppressive drugs, as those specified
in this protocol

- Patients receiving bile acid sequestrants

- Psychological illness or condition, interfering with the patient's compliance or
ability to understand the requirements of the study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess if superior graft function (GFR difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de novo kidney transplant patients treated with Myfortic-everolimus plus steroids compared to Myfortic-cyclosporine.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Jean-Louis Bosmans, MD/PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Antwerp - Department Nephrology-Hypertension

Authority:

European Union: European Medicines Agency

Study ID:

2007-005844-26

NCT ID:

NCT00903188

Start Date:

October 2008

Completion Date:

April 2015

Related Keywords:

  • Renal Transplantation
  • Renal Transplantation
  • graft function
  • cardiovascular events
  • malignancy
  • cyclosporin
  • steroids
  • mycophenolate
  • everolimus
  • renal biopsies
  • pharmacokinetics

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