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A Controlled Randomized Open-label Multicenter Study Evaluating if Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients Can Improve Long-term Renal Function and Slow Down the Progression of Chronic Allograft Nephropathy


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Chronic Allograft Nephropathy

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Trial Information

A Controlled Randomized Open-label Multicenter Study Evaluating if Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients Can Improve Long-term Renal Function and Slow Down the Progression of Chronic Allograft Nephropathy


Inclusion Criteria:



- First or second single renal transplant from deceased or living donor

Exclusion criteria

- Recipient of organs other than a renal transplant

- Present malignancy (within the last 2 years) other than excised basal cell or
squamous cell carcinoma of the skin

- Severe liver disease

- At the time of randomization 7 weeks after transplantation

In addition to the above criteria the following must be met at time of randomization:

Inclusion Criteria:



- Patients maintained on a triple immunosuppressive regime consisting of cyclosporine,
Enteric coated mycophenolate, and corticosteroids

- Patients completed the first 7 weeks without experiencing any rejection

Exclusion Criteria:

- Graft loss

- Low hemoglobin value, low number of white blood cells or platelets

- High cholesterol values

- Proteinuria

- Wound healing problems

- Current severe major local or systemic infection

- Renal insufficiency

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Renal function measured by Iohexol or Cr EDTA (Crom Ethylenediaminotetra acetate) clearance at randomization after 12 and 36 months

Outcome Time Frame:

12 and 36 months

Safety Issue:

No

Authority:

Sweden: Medical Products Agency

Study ID:

CRAD001ASE01

NCT ID:

NCT00634920

Start Date:

March 2008

Completion Date:

Related Keywords:

  • Chronic Allograft Nephropathy
  • De novo renal transplantation
  • Kidney Diseases

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