Switching From One Type of Anti-rejection Drug (Tacrolimus or Cyclosporine) to Another (Sirolimus) Approximately 90-180 Days After Liver Transplantation

NCT00834496

Last updated date
Study Location
THomas Jefferson University and Hospital
Philadelphia, Pennsylvania, 19107, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Side Effects of Calcineurin Inhibitors, Renal Toxicity, Hepatic Fibrosis on Biopsy, Neurotoxicity, Post Transplant Diabetes
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Side Effects of Calcineurin Inhibitors, Renal Toxicity, Hepatic Fibrosis on Biopsy, Neurotoxicity, Post Transplant DiabetesSwitching From One Type of Anti-rejection Drug (Tacrolimus or Cyclosporine) to Another (Sirolimus) Approximately 90-180 Days After Liver Transplantation
NCT00834496
  1. Philadelphia, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
  • Side Effects of Calcineurin Inhibitors
  • Renal Toxicity
  • Hepatic Fibrosis on Biopsy
  • Neurotoxicity
  • Post Transplant Diabetes
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:

  • CNI renal toxicity.
  • Hepatic fibrosis on biopsy.
  • CNI neurologic toxicity.
  • Post transplant diabetes. Any of the above 4 indications makes a patient a candidate for conversion from CNIs to Sirolimus at or > 90 days after liver transplantation.
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
 (submitted: January 11, 2017)
0
Original Estimated Enrollment
 (submitted: February 2, 2009)
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:

  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.

Exclusion Criteria:

  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
Sex/Gender
Sexes Eligible for Study:All
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
Principal Investigator:Cataldo Doria, MD, PhDThomas Jefferson University and Hospital
PRS Account Thomas Jefferson University
Verification Date January 2017