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Sponsors and Collaborators: |
Rabin Medical Center Novartis |
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Information provided by: | Rabin Medical Center |
ClinicalTrials.gov Identifier: | NCT00443508 |
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.
Condition | Intervention | Phase |
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Kidney Diseases |
Drug: adding Certican to therapy Drug: reducing Tacrolimus |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 60 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2010 |
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:
The following parameters will be monitored every clinic visit throughout the study period:
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:
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eytan Mor, Prof | 00973 3 9376528 | emor@clalit.org.il |
Contact: Ruti rahamimov, Dr | 00973 3 9376528 | rutir@clalit.org.il |
Israel | |
Transplantation department, rabin Medical Center | Recruiting |
Petach Tikva, Israel, 49202 | |
Contact: Eytan Mor, Prof 00937 3 9376528 tikim@clalit.org.il | |
Principal Investigator: Eytan Mor, Prof | |
Sub-Investigator: Ruti Rahamimov, Dr | |
Sub-Investigator: Alex Yusim, Dr |
Principal Investigator: | Eytan Mor, Prof | Rabin Medical Center, head of Transplantation department |
Study ID Numbers: | CRAD001AIL01 |
Study First Received: | March 4, 2007 |
Last Updated: | March 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00443508 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
everolimus renal transplant tacrolimus |
Certican CHRONIC ALLOGRAFT NEPHROPATHY Renal transplant patients |
Everolimus Immunologic Factors Urologic Diseases |
Tacrolimus Kidney Diseases Immunosuppressive Agents |
Everolimus Immunologic Factors Urologic Diseases Physiological Effects of Drugs |
Tacrolimus Kidney Diseases Immunosuppressive Agents Pharmacologic Actions |