Renal TransplantPhase 4NCT00352092
Pilot Study for HLA Identical Living Donor Renal Transplant Recipients
A Phase 4 study testing calcineurin inhibitor, sirolimus and mycophenolate mofetil in people with Renal Transplant, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of a steroid-free and calcineurin-inhibitor free treatment regimen for patients who are receiving a kidney transplant from a living donor that is HLA-identical (has a similar immune system). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Transplant
- What is being tested?
- calcineurin inhibitor, sirolimus and mycophenolate mofetil
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Dec 2007
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years
- Male/female recipients
- All ethnic groups
- Negative pregnancy test
- Practicing an acceptable form of birth control
- Signing informed consent
Who cannot join
- Known sensitivity or contraindication to mycophenolate mofetil, tacrolimus, or sirolimus
- Re-transplants who lost primary transplant from immunologic causes (patients with graft loss secondary to technical or calcineurin-inhibitor toxicity will be included)
- Liver, heart, pancreas or small bowel transplant recipient
- Fasting total cholesterol >300 mg/dL and fasting triglycerides >400 mg/dL
- Baseline WBC count <3000/cu.mm
- Baseline platelet count <100,000/cu.mm
- Known or suspected malignancy within previous 3 years, (Patients with squamous cell and basal skin cancer are not excluded)
- Active systemic infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Corticosteroid-Free, Calcineurin-Sparing Immunosuppression Protocol for HLA-Identical Living Donor Renal Transplant Recipient
The purpose of this study is to evaluate the safety and effectiveness of a steroid-free and calcineurin-inhibitor free treatment regimen for patients who are receiving a kidney transplant from a living donor that is HLA-identical (has a similar immune system).
Read the detailed description
The purpose of this study is to evaluate the safety and effectiveness of a steroid-free and calcineurin-inhibitor free treatment regimen for patients who are receiving a kidney transplant from a living donor that is HLA - identical, or in other words, has a similar immune system. The immune system is a defense system that the body uses to fight foreign substances that enter the body, such as a transplanted kidney. Two people with similar immune systems are less likely to fight off or reject an organ donated from one to the other. HLA-identical kidney transplant recipients are less likely to need large amounts of immunosuppression because they are immunologically similar. In this study, you will be treated with the immunosuppressive medications, Cellcept, Rapamune, and Prograf and after a rejection free period will remain on Cellcept alone. This treatment regimen is currently being used at The University of Cincinnati for all HLA-identical living donor kidney transplant recipients. This study is being conducted to determine if the protocol currently being used results in beneficial outcomes for HLA-identical kidney transplant recipients.
Only recently have transplant centers considered avoiding steroid therapy (prednisone) in any transplant patient because steroids have been used successfully for so long, but with many side effects. The ability to stop steroids has occurred due to the availability of newer more effective immunosuppressive medications. Stopping steroids has been tried in patients who are considered to be at both low and higher risk of kidney rejection. Patients considered at risk for rejection may typically be left on steroids forever or no attempts to stop the steroids would be made until the patient is one year after transplant and has already received a lot of steroid therapy resulting in side effects. This study will be conducted in patients that are low risk for rejection and can potentially benefit from steroid avoidance.
Overall, the concept of steroid avoidance in patients that are at low risk for rejection is now much more acceptable because newer, more potent medications have recently become available to prevent acute rejection. These newer medications include Prograf (tacrolimus), Cellcept (mycophenolate mofetil), and Rapamune (sirolimus). Currently, most kidney transplant recipients receive medications consisting of tacrolimus or cyclosporine, mycophenolate mofetil or azathioprine, and steroids. However, recently, the combination of Prograf (tacrolimus) and Rapamune (sirolimus) with steroid withdrawal 3 months after transplantation was studied in patients receiving liver, liver/kidney, and kidney/pancreas transplants. This study showed a low rate of acute rejection with excellent patient and kidney survival.
The addition of Cellcept to Prograf and Rapamune is thought to be a safe and effective alternative to the use of steroids in transplant patients. Due to the low risk of rejection for HLA-identical kidney transplant recipients, patients in this study will be slowly withdrawn from both Rapamune and Prograf over a rejection free period of time. Withdrawal of these medications and avoidance of steroids could decrease the development of high blood pressure, high cholesterol, diabetes, tremors, and infection after transplant. This study will determine if this medication regimen is safe, effective, and able to produce beneficial post transplant outcomes.
- Conditions
- Renal Transplant
- Being tested
- calcineurin inhibitor, sirolimus, mycophenolate mofetil
- Keywords
- Kidney disease, Renal transplant, HLA Identical, Living Donor, Corticosteroid free, Calcineurin sparing, Adults
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcineurin inhibitorDrug
sirolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of biopsy confirmed acute rejection at 12 and 24 months.
Secondary outcomes (11)
Patient survival
Graft survival
Early discontinuation of mycophenolate mofetil, tacrolimus, or sirolimus due to toxicity
Time to acute rejection from transplant
Severity of acute rejection measure by Banff'93 criteria, and/or requirement of antilymphocyte treatment; need for corticosteroid pulse or maintenance therapy for rejection or recurrent disease
Evaluation of 24-hour proteinuria at 24 months post-transplant
Evaluation of graft function by calculated CrCl (Cockroft-Gault) at 1, 3, 6, 12, and 24 months post-transplant
Patient weight
Quantitative bone loss
Cholesterol and triglyceride levels at 12 and 24 months
Cardiovascular risk assessment by Framingham criteria at 0, 1, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startJun 2002
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Rita Alloway, University of Cincinnati
- Investigators
- Rita Alloway, Pharm.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352092
- Sponsor's protocol ID
- CEL313
- Status last verified
- Nov 2014
- First submitted
- 13 Jul 2006
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Corticosteroid-Free, Calcineurin-Sparing Immunosuppression Protocol for HLA-Identical Living Donor Renal Transplant Recipient
- ClinicalTrials.gov ID
- NCT00352092
- Acronym / sponsor ID
- CEL313
- Conditions
- Renal Transplant
- Keywords
- Kidney disease, Renal transplant, HLA Identical, Living Donor, Corticosteroid free, Calcineurin sparing, Adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jun 2002
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 Jul 2006 (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.
The purpose of this study is to evaluate the safety and effectiveness of a steroid-free and calcineurin-inhibitor free treatment regimen for patients who are receiving a kidney transplant from a living donor that is HLA-identical (has a similar immune system).
Detailed description
The purpose of this study is to evaluate the safety and effectiveness of a steroid-free and calcineurin-inhibitor free treatment regimen for patients who are receiving a kidney transplant from a living donor that is HLA - identical, or in other words, has a similar immune system. The immune system is a defense system that the body uses to fight foreign substances that enter the body, such as a transplanted kidney. Two people with similar immune systems are less likely to fight off or reject an organ donated from one to the other. HLA-identical kidney transplant recipients are less likely to need large amounts of immunosuppression because they are immunologically similar. In this study, you will be treated with the immunosuppressive medications, Cellcept, Rapamune, and Prograf and after a rejection free period will remain on Cellcept alone. This treatment regimen is currently being used at The University of Cincinnati for all HLA-identical living donor kidney transplant recipients. This study is being conducted to determine if the protocol currently being used results in beneficial outcomes for HLA-identical kidney transplant recipients.
Only recently have transplant centers considered avoiding steroid therapy (prednisone) in any transplant patient because steroids have been used successfully for so long, but with many side effects. The ability to stop steroids has occurred due to the availability of newer more effective immunosuppressive medications. Stopping steroids has been tried in patients who are considered to be at both low and higher risk of kidney rejection. Patients considered at risk for rejection may typically be left on steroids forever or no attempts to stop the steroids would be made until the patient is one year after transplant and has already received a lot of steroid therapy resulting in side effects. This study will be conducted in patients that are low risk for rejection and can potentially benefit from steroid avoidance.
Overall, the concept of steroid avoidance in patients that are at low risk for rejection is now much more acceptable because newer, more potent medications have recently become available to prevent acute rejection. These newer medications include Prograf (tacrolimus), Cellcept (mycophenolate mofetil), and Rapamune (sirolimus). Currently, most kidney transplant recipients receive medications consisting of tacrolimus or cyclosporine, mycophenolate mofetil or azathioprine, and steroids. However, recently, the combination of Prograf (tacrolimus) and Rapamune (sirolimus) with steroid withdrawal 3 months after transplantation was studied in patients receiving liver, liver/kidney, and kidney/pancreas transplants. This study showed a low rate of acute rejection with excellent patient and kidney survival.
The addition of Cellcept to Prograf and Rapamune is thought to be a safe and effective alternative to the use of steroids in transplant patients. Due to the low risk of rejection for HLA-identical kidney transplant recipients, patients in this study will be slowly withdrawn from both Rapamune and Prograf over a rejection free period of time. Withdrawal of these medications and avoidance of steroids could decrease the development of high blood pressure, high cholesterol, diabetes, tremors, and infection after transplant. This study will determine if this medication regimen is safe, effective, and able to produce beneficial post transplant outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 70 years
- Male/female recipients
- All ethnic groups
- Negative pregnancy test
- Practicing an acceptable form of birth control
Key exclusion criteria (8 listed)
- Known sensitivity or contraindication to mycophenolate mofetil, tacrolimus, or sirolimus
- Re-transplants who lost primary transplant from immunologic causes (patients with graft loss secondary to technical or calcineurin-inhibitor toxicity will be included)
- Liver, heart, pancreas or small bowel transplant recipient
- Fasting total cholesterol >300 mg/dL and fasting triglycerides >400 mg/dL
- Baseline WBC count <3000/cu.mm
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 |
|---|---|---|
| calcineurin inhibitor | Drug | – |
| sirolimus | Drug | – |
| mycophenolate mofetil | Drug | – |
Primary outcome
Incidence of biopsy confirmed acute rejection at 12 and 24 months.
11 secondary outcomes
Patient survival
Graft survival
Early discontinuation of mycophenolate mofetil, tacrolimus, or sirolimus due to toxicity
Time to acute rejection from transplant
Severity of acute rejection measure by Banff'93 criteria, and/or requirement of antilymphocyte treatment; need for corticosteroid pulse or maintenance therapy for rejection or recurrent disease
Evaluation of 24-hour proteinuria at 24 months post-transplant
Evaluation of graft function by calculated CrCl (Cockroft-Gault) at 1, 3, 6, 12, and 24 months post-transplant
Patient weight
Quantitative bone loss
Cholesterol and triglyceride levels at 12 and 24 months
Cardiovascular risk assessment by Framingham criteria at 0, 1, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
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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.
Rita Alloway, Pharm.D. principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing calcineurin inhibitor, sirolimus and mycophenolate mofetil in people with Renal Transplant, run by University of Cincinnati 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 13 Nov 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of biopsy confirmed acute rejection at 12 and 24 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 13 Nov 2014.