UnknownPhase 4

Reduction or Discontinuation of CNI's With Conversion to Everolimus-Based Immunosuppresion

Israel60 participantsStarted 2007-02

Plain-language summary

This study is design to compare two different strategies aiming to lessen the degree of the ongoing process of allograft injury either by removing tacrolimus from the maintenance immunosuppressive protocol or by reducing tacrolimus dose. The primary goal is to assess the change in renal function at 6 and 12 months after conversion using creatinine levels and calculated creatinine clearance. The study will include two groups: The study group of 30 patients and a matched control group with creatinine levels at similar range.

Who can participate

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients on CNI FK \< 5 ng/m"l with MPA / Imuran with or without steroids * Renal impairment GFR between 30 - 70 m"l/minute/ * Patient who signed Informed consent * Patient with no contraindication to renal biopsy * Women who are not pregnant and will use contraception Exclusion Criteria: * Proteinuria \> 100 m"g/mmol Creatinine * Acute rejection during 3 months before screening * WBC \< 2500, plt \< 50,000, * Nephropathy due to polyoma virus * Patients on other investigational drugs * Patients on rapamycin * Patients with HIV or other systemic infection * Inability to comply with protocol requirements * Active or history of malignancy

What they're measuring

The primary goal is to assess the change in renal function

at 6 and 12 months after conversion using creatinine levels

and calculated creatinine clearance.

Trial details

NCT IDNCT00443508

SponsorRabin Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Contact for this trial

Eytan Mor, Prof

00973 3 9376528 emor@clalit.org.il

View on ClinicalTrials.gov More Kidney Diseases trials