Switching From One Type of Anti-rejection Drug (Tacrolimus or Cyclosporine) to Another (Sirolimus) Approximately 90-180 Days After Liver Transplantation
NCT00834496
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Adult Trials: 18+ Years
1. Adult (18 years or older) patients undergoing liver transplantation at Thomas Jefferson University Hospital.
2. Diagnosed with at least one of the following CNI side effects 90-180 days post transplantation:
1. CNI renal toxicity. Any liver transplant recipient who has elevated creatinine level (greater than 1.4 mg/dl) and impaired creatinine clearance (MDRD) of 40-60 ml/minute or decreased by 15% compared to baseline in the setting of having a therapeutic CNI level, without suspicion of acute or chronic allograft rejection.
2. Hepatic fibrosis on biopsy. Any patient who has fibrosis seen on liver biopsy with LFT's 2 times the upper normal limit.
3. CNI neurologic toxicity. Any patient who has significant neurological side effects from CNIs. This will include the following: seizures not secondary to an epileptogenic focus or any metabolic derangement; alteration of speech ranging from aphasia to slurred speech; inability to be awake and alert.
4. Post transplant diabetes. Any patient who has developed diabetes after transplant and in whom CNIs are thought to be contributing to poor glycemic control.
3. Signed informed consent at approximately 90 -180 days post transplantation.
1. Invasive/surgical therapy within 2 weeks of the 90-180 day post transplantation
conversion. (e.g. patients with T-tubes would not be eligible for the study because
the T-tube removal will coincide with the conversion date).
2. Open surgical wound at 90-180 days post transplantation.
3. Acute cellular rejection during the first 90-180 days post transplantation.
4. Re-transplants or multiple-organ transplants.
5. Active infection.
6. Pregnancy.
7. Malignancy within 3 years prior to liver transplantation (except adequately treated
basal cell carcinoma). Patients with HCC prior to transplant will not be excluded.
8. Total cholesterol >300 mg/dl on medical treatment or triglycerides >150 mg/dl at
90-180 days post transplantation.
9. White blood cell count <3,000/mm3 or platelet count <100,000/mm3 at 90-180 days post
transplantation.
10. Ascites.
11. Patients on chemotherapy.
12. Urine protein/creatinine ration > 0.5
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Switching From One Type of Anti-rejection Drug (Tacrolimus or Cyclosporine) to Another (Sirolimus) Approximately 90-180 Days After Liver Transplantation | |||
| Official Title | Sirolimus Switching From Calcinurin Inhibitors (CNI) 90 - 180 Days After Liver Transplantation | |||
| Brief Summary | Sirolimus can be safely switched as early as 90 days after liver transplantation with excellent tolerability and amelioration of the calcineurin inhibitor toxicity that initiated the switch. | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | post liver transplant patients taking calcineurin inhibitors (tacrolimus or cyclosporine) as anti-reject medication | |||
| Condition |
| |||
| Intervention | Procedure: Liver biopsy
percutaneous liver biopsy | |||
| Study Groups/Cohorts | 1
Our experience with the use of Sirolimus is delineated below. About 15% to 20% of our patients are currently switched to Sirolimus.Indications for conversion from calcinurin inhibitors (CNIs) to Sirolimus more than 90 days post liver transplantation include:
Intervention: Procedure: Liver biopsy | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Withdrawn | |||
| Actual Enrollment | 0 | |||
| Original Estimated Enrollment | 40 | |||
| Actual Study Completion Date | January 2010 | |||
| Actual Primary Completion Date | January 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00834496 | |||
| Other Study ID Numbers | 08D.12 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Thomas Jefferson University | |||
| Study Sponsor | Thomas Jefferson University | |||
| Collaborators | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Investigators |
| |||
| PRS Account | Thomas Jefferson University | |||
| Verification Date | January 2017 | |||