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

March 5, 2007 updated by: Rabin Medical Center

Reduction or Discontinuation of Calcineurine Inhibitors With Conversion to Everolimus-Based Immunosuppresion to Alleviate Chronic Allograft Nephropathy (CAN) in Kidney Transplant Recipients: A Prospective Randomized Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Patients will undergo the following baseline studies:

  1. Doppler ultrasound to exclude any mechanical or a vascular problem.
  2. A kidney biopsy to define the histological changes (degree of interstitial fibrosis, tubular and glomerular changes). The biopsies will be stained also for C4D and for fibrinogenic markers (TGF-beta, and collagen).
  3. A 24-hour urine protein excretion and creatinine clearance
  4. Echocardiography study
  5. Carotid Ultrasound

The following parameters will be monitored every clinic visit throughout the study period:

  1. SMA-12 including creatinine levels.
  2. A complete blood count.
  3. Cholesterol, HDL-cholesterol and triglyceride levels.
  4. Blood pressure measurements (X2)
  5. The number of blood pressure medications.
  6. Cholesterol lowering medication requirement
  7. Urine protein excretion (quantitative spot-test )
  8. Protein amount in the urine

Study end points:

The data will be evaluated based on an intention to treat analysis and the following parameters will be compared between the two groups:

  1. Creatinine levels and calculated creatinine clearance
  2. Spot urine for Cr./protein ratio
  3. 24-hr. protein excretion
  4. Change in peak diastolic and mean arterial blood pressure
  5. The number and dosage of blood pressure medications
  6. Cholesterol, HDL and triglyceride levels
  7. Proportion of patients on cholesterol lowering agents
  8. Number and severity of biopsy proven acute rejection episodes
  9. Incidence of biopsy proven chronic rejection. (depends on per protocol biopsy at end of study)
  10. Patient and graft survival

Study Type

Interventional

Enrollment

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Petach Tikva, Israel, 49202
        • Recruiting
        • Transplantation department, rabin Medical Center
        • Contact:
        • Principal Investigator:
          • Eytan Mor, Prof
        • Sub-Investigator:
          • Ruti Rahamimov, Dr
        • Sub-Investigator:
          • Alex Yusim, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Collaborators

Novartis

Investigators

  • Principal Investigator: Eytan Mor, Prof, Rabin Medical Center, head of Transplantation department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Study Completion

February 1, 2010

Study Registration Dates

First Submitted

March 4, 2007

First Submitted That Met QC Criteria

March 5, 2007

First Posted (Estimate)

March 6, 2007

Study Record Updates

Last Update Posted (Estimate)

March 6, 2007

Last Update Submitted That Met QC Criteria

March 5, 2007

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001AIL01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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