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

NCT00443508 | Unknown Phase 4

• 1 other identifier: CRAD001AIL01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Diseases

Keywords

everolimus; renal transplant; tacrolimus; Certican; CHRONIC ALLOGRAFT NEPHROPATHY; Renal transplant patients

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (4)

• The secondary aim is to assess changes in cardiovascular risks at

• 12 months after conversion (glucose control., cholesterol and

• triglyceride levels and hypertension control), incidence of

• acute and chronic rejection and graft and patient survival rates.

Interventions

adding Certican to therapy DRUG

reducing Tacrolimus DRUG

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead
• Novartis: collaborator

Study Sites (1)

Transplantation department, rabin Medical Center

Petah Tikva, 49202, Israel

RECRUITING

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Eytan Mor, Prof

  Rabin Medical Center, head of Transplantation department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eytan Mor, Prof

CONTACT

00973 3 9376528; emor@clalit.org.il

Ruti rahamimov, Dr

CONTACT

00973 3 9376528; rutir@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 4, 2007
• First Posted: March 6, 2007
• Study Start: February 1, 2007
• Study Completion: February 1, 2010
• Last Updated: March 6, 2007

Record last verified: 2005-09

Locations

IL (1)