Side Effects of Calcineurin InhibitorsNCT00834496
Switching From One Type of Anti-rejection Drug (Tacrolimus or Cyclosporine) to Another (Sirolimus) Approximately 90-180 Days After Liver Transplantation
An observational study of Side Effects of Calcineurin Inhibitors and Renal Toxicity, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Side Effects of Calcineurin Inhibitors, Renal Toxicity, Hepatic Fibrosis on Biopsy
- What is being tested?
- Liver biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: post liver transplant patients taking calcineurin inhibitors (tacrolimus or cyclosporine) as anti-reject medication
Who may be able to join
- Adult (18 years or older) patients undergoing liver transplantation at Thomas Jefferson University Hospital.
- Diagnosed with at least one of the following CNI side effects 90-180 days post transplantation:
- 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.
- Hepatic fibrosis on biopsy. Any patient who has fibrosis seen on liver biopsy with LFT's 2 times the upper normal limit.
- 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.
- Post transplant diabetes. Any patient who has developed diabetes after transplant and in whom CNIs are thought to be contributing to poor glycemic control.
- Signed informed consent at approximately 90 -180 days post transplantation.
Who cannot join
- 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).
- Open surgical wound at 90-180 days post transplantation.
- Acute cellular rejection during the first 90-180 days post transplantation.
- Re-transplants or multiple-organ transplants.
- Active infection.
- Pregnancy.
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- Malignancy within 3 years prior to liver transplantation (except adequately treated basal cell carcinoma). Patients with HCC prior to transplant will not be excluded.
- Total cholesterol >300 mg/dl on medical treatment or triglycerides >150 mg/dl at 90-180 days post transplantation.
- White blood cell count <3,000/mm3 or platelet count <100,000/mm3 at 90-180 days post transplantation.
- Ascites.
- Patients on chemotherapy.
- Urine protein/creatinine ration > 0.5
Trial locations and contacts
1 site in 1 country.
United States1 site
THomas Jefferson University and Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Sirolimus Switching From Calcinurin Inhibitors (CNI) 90 - 180 Days After Liver Transplantation
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.
- Conditions
- Side Effects of Calcineurin Inhibitors, Renal Toxicity, Hepatic Fibrosis on Biopsy, Neurotoxicity, Post Transplant Diabetes
- Being tested
- Liver biopsy
- Medical subject headings
- Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver biopsyProcedure or surgery
percutaneous liver biopsy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is that acute cellular rejection following a switch to sirolimus will be comparable to the historical rate at our center under calcineurin inhibitors of around 5% for post liver transplant recipients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Side Effects of Calcineurin InhibitorsStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Cataldo Doria, MD, PhD, Principal investigator, Thomas Jefferson University and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834496
- Sponsor's protocol ID
- 08D.12
- Status last verified
- Jan 2017
- First submitted
- 30 Jan 2009
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sirolimus Switching From Calcinurin Inhibitors (CNI) 90 - 180 Days After Liver Transplantation
- ClinicalTrials.gov ID
- NCT00834496
- Acronym / sponsor ID
- 08D.12
- Conditions
- Side Effects of Calcineurin Inhibitors, Renal Toxicity, Hepatic Fibrosis on Biopsy, Neurotoxicity, Post Transplant Diabetes
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Liver biopsyOur 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- post liver transplant patients taking calcineurin inhibitors (tacrolimus or cyclosporine) as anti-reject medication
Key inclusion criteria (7 listed)
- Adult (18 years or older) patients undergoing liver transplantation at Thomas Jefferson University Hospital.
- Diagnosed with at least one of the following CNI side effects 90-180 days post transplantation:
- Signed informed consent at approximately 90 -180 days post transplantation.
Key exclusion criteria (12 listed)
- 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).
- Open surgical wound at 90-180 days post transplantation.
- Acute cellular rejection during the first 90-180 days post transplantation.
- Re-transplants or multiple-organ transplants.
- Active infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver biopsypercutaneous liver biopsy | Procedure or surgery | 1 |
Primary outcome
The primary objective is that acute cellular rejection following a switch to sirolimus will be comparable to the historical rate at our center under calcineurin inhibitors of around 5% for post liver transplant recipients.
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cataldo Doria, MD, PhD principal investigator
Thomas Jefferson University and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Side Effects of Calcineurin Inhibitors and Renal Toxicity, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is that acute cellular rejection following a switch to sirolimus will be comparable to the historical rate at our center under calcineurin inhibitors of around 5% for post liver transplant recipients. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.