Absence; KidneyNCT01005706
Sirolimus Conversions in African-American Renal Transplant Recipients
A study testing rapamune, mycophenolate mofetil and steroid and tacrolimus, sirolimus and steroid in people with Absence; Kidney, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study's focus is to compare the level effectiveness and safety of regimens involving Sirolimus, Cellcept and steroid to Prograf, Sirolimus and steroid in African-American recipients of kidney transplants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Absence; Kidney
- What is being tested?
- rapamune, mycophenolate mofetil and steroid and tacrolimus, sirolimus and steroid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- At least 18 years of age and able to give informed consent
- African-American ethnicity
- Received a first or second non-ECD cadaveric or living donor renal transplant
- Transplant occurred during the past 6 to 24 weeks
- Patient has stable graft function, defined as no change of greater than 30% of baseline serum creatinine during the past month and no acute rejection in the past 6 weeks
- Estimated GFR using the modified MDRD equation of at least 40 mL/min10 at time of enrollment into the study
- Currently receiving tacrolimus, mycophenolate mofetil (at least 1 gm per day), and corticosteroids as their immunosuppression regimen.
Who cannot join
- Biopsy proven acute rejection episode that occurred within the past 6 weeks
- Malignancy within the past 3 years, except for non-melanoma skin cancer
- Any known intolerances to current immunosuppressant regimen necessitating withdrawal of the offending agent
- Currently enrolled in an investigational trial
- Woman of child bearing potential not utilizing an effective form of birth control
- Patients with uncontrolled dyslipidemia, defined at serum fasting LDL >200 mg/dL or serum fasting triglycerides >500 mg/dL.
Show all 9Show fewer
- Patients with a spot urine protein to creatinine ratio of > 800 mg of protein per gram of creatinine.
- WBC < 3,000 cells/mm3
- Platelets < 100,000 cells/mm3
Trial locations and contacts
1 site in 1 country.
United States1 site
The Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Pilot Study Comparing Two Different Sirolimus-based Transition Regimens in African-American Renal Transplant Recipients
This study's focus is to compare the level effectiveness and safety of regimens involving Sirolimus, Cellcept and steroid to Prograf, Sirolimus and steroid in African-American recipients of kidney transplants.
Read the detailed description
A major concern in transplantation is finding a successful regimen of medications to lower the potential for the body to reject the newly transplanted organ. The regimens in kidney transplantation include tacrolimus, sirolimus, mycophenolate mofetil and steroids. This study will compare the effectiveness and safety of a regimen including Sirolimus, Prograf, and steroids compared to a regimen including Sirolimus, Cellcept and steroids. These regimens have already been researched in the Caucasian population, and both drug regimens are FDA approved. This study's focus is on the effectiveness and safety of these regimens in African-Americans.
- Conditions
- Absence; Kidney
- Being tested
- rapamune, mycophenolate mofetil and steroid, tacrolimus, sirolimus and steroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapamune, mycophenolate mofetil and steroidDrug
Also called rapamune (Sirolimus), mycophenolate mofetil (Cellcept)
At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.
Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator.
tacrolimus, sirolimus and steroidDrug
Also called tacrolimus (Prograf), rapamune (Sirolimus)
Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.
At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus Withdrawal Arm | Active comparator | At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.
Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator. Receives: Drug: rapamune, mycophenolate mofetil and steroid |
| Tacrolimus Minimization Arm | Active comparator | Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.
At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml. Receives: Drug: tacrolimus, sirolimus and steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness and Safety of a Particular Drug Regimen to Prevent Kidney Rejection
Number of Participants with Kidney Rejections
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 posted2 Nov 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Absence; KidneyStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Charles Bratton, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005706
- Sponsor's protocol ID
- Wyeth Study - HR 19042
- Other IDs
- HR19042
- Status last verified
- Feb 2014
- First submitted
- 9 Oct 2009
- Last updated
- 11 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kahan BD, Camardo JS. Rapamycin: clinical results and future opportunities. Transplantation. 2001 Oct 15;72(7):1181-93. doi: 10.1097/00007890-200110150-00001. No abstract available.
PubMed 11602840Sehgal SN. Rapamune (RAPA, rapamycin, sirolimus): mechanism of action immunosuppressive effect results from blockade of signal transduction and inhibition of cell cycle progression. Clin Biochem. 1998 Jul;31(5):335-40. doi: 10.1016/s0009-9120(98)00045-9.
PubMed 9721431MacDonald A, Scarola J, Burke JT, Zimmerman JJ. Clinical pharmacokinetics and therapeutic drug monitoring of sirolimus. Clin Ther. 2000;22 Suppl B:B101-121. doi: 10.1016/s0149-2918(00)89027-x.
PubMed 10823378Ingle GR, Sievers TM, Holt CD. Sirolimus: continuing the evolution of transplant immunosuppression. Ann Pharmacother. 2000 Sep;34(9):1044-55. doi: 10.1345/aph.19380.
PubMed 10981252El-Sabrout R, Delaney V, Butt F, Qadir M, Hanson P, Tuteja S, McCollum DA, Butt K. Improved freedom from rejection after a loading dose of sirolimus. Transplantation. 2003 Jan 15;75(1):86-90. doi: 10.1097/00007890-200301150-00016.
PubMed 12544877Podder H, Stepkowski SM, Napoli KL, Clark J, Verani RR, Chou TC, Kahan BD. Pharmacokinetic interactions augment toxicities of sirolimus/cyclosporine combinations. J Am Soc Nephrol. 2001 May;12(5):1059-1071. doi: 10.1681/ASN.V1251059.
PubMed 11316866Groth CG, Backman L, Morales JM, Calne R, Kreis H, Lang P, Touraine JL, Claesson K, Campistol JM, Durand D, Wramner L, Brattstrom C, Charpentier B. Sirolimus (rapamycin)-based therapy in human renal transplantation: similar efficacy and different toxicity compared with cyclosporine. Sirolimus European Renal Transplant Study Group. Transplantation. 1999 Apr 15;67(7):1036-42. doi: 10.1097/00007890-199904150-00017.
PubMed 10221490MacDonald A. Improving tolerability of immunosuppressive regimens. Transplantation. 2001 Dec 27;72(12 Suppl):S105-12.
PubMed 11833142Fleming JN, Taber DJ, Pilch NA, McGillicuddy JW, Srinivas TR, Baliga PK, Chavin KD, Bratton CF. A randomized, prospective comparison of transition to sirolimus-based CNI-minimization or withdrawal in African American kidney transplant recipients. Clin Transplant. 2016 May;30(5):528-33. doi: 10.1111/ctr.12718. Epub 2016 Mar 14.
PubMed 26914542
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Comparing Two Different Sirolimus-based Transition Regimens in African-American Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT01005706
- Acronym / sponsor ID
- Wyeth Study - HR 19042
- Conditions
- Absence; Kidney
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Aug 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Posted 11 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study's focus is to compare the level effectiveness and safety of regimens involving Sirolimus, Cellcept and steroid to Prograf, Sirolimus and steroid in African-American recipients of kidney transplants.
Detailed description
A major concern in transplantation is finding a successful regimen of medications to lower the potential for the body to reject the newly transplanted organ. The regimens in kidney transplantation include tacrolimus, sirolimus, mycophenolate mofetil and steroids. This study will compare the effectiveness and safety of a regimen including Sirolimus, Prograf, and steroids compared to a regimen including Sirolimus, Cellcept and steroids. These regimens have already been researched in the Caucasian population, and both drug regimens are FDA approved. This study's focus is on the effectiveness and safety of these regimens in African-Americans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus Withdrawal Arm | Active comparator | Drug: rapamune, mycophenolate mofetil and steroidAt the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml. Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator. |
| Tacrolimus Minimization Arm | Active comparator | Drug: tacrolimus, sirolimus and steroidTacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml. At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age and able to give informed consent
- African-American ethnicity
- Received a first or second non-ECD cadaveric or living donor renal transplant
- Transplant occurred during the past 6 to 24 weeks
- Patient has stable graft function, defined as no change of greater than 30% of baseline serum creatinine during the past month and no acute rejection in the past 6 weeks
Key exclusion criteria (9 listed)
- Biopsy proven acute rejection episode that occurred within the past 6 weeks
- Malignancy within the past 3 years, except for non-melanoma skin cancer
- Any known intolerances to current immunosuppressant regimen necessitating withdrawal of the offending agent
- Currently enrolled in an investigational trial
- Woman of child bearing potential not utilizing an effective form of birth control
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 |
|---|---|---|
| rapamune, mycophenolate mofetil and steroidAlso: rapamune (Sirolimus), mycophenolate mofetil (Cellcept)At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml. Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator. | Drug | Tacrolimus Withdrawal Arm |
| tacrolimus, sirolimus and steroidAlso: tacrolimus (Prograf), rapamune (Sirolimus)Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml. At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml. | Drug | Tacrolimus Minimization Arm |
Primary outcome
Effectiveness and Safety of a Particular Drug Regimen to Prevent Kidney Rejection
Time frame: 12 months
Number of Participants with Kidney Rejections
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11602840Kahan BD, Camardo JS. Rapamycin: clinical results and future opportunities. Transplantation. 2001 Oct 15;72(7):1181-93. doi: 10.1097/00007890-200110150-00001. No abstract available.
- Background: PubMed 9721431Sehgal SN. Rapamune (RAPA, rapamycin, sirolimus): mechanism of action immunosuppressive effect results from blockade of signal transduction and inhibition of cell cycle progression. Clin Biochem. 1998 Jul;31(5):335-40. doi: 10.1016/s0009-9120(98)00045-9.
- Background: PubMed 10823378MacDonald A, Scarola J, Burke JT, Zimmerman JJ. Clinical pharmacokinetics and therapeutic drug monitoring of sirolimus. Clin Ther. 2000;22 Suppl B:B101-121. doi: 10.1016/s0149-2918(00)89027-x.
- Background: PubMed 10981252Ingle GR, Sievers TM, Holt CD. Sirolimus: continuing the evolution of transplant immunosuppression. Ann Pharmacother. 2000 Sep;34(9):1044-55. doi: 10.1345/aph.19380.
- Background: PubMed 12544877El-Sabrout R, Delaney V, Butt F, Qadir M, Hanson P, Tuteja S, McCollum DA, Butt K. Improved freedom from rejection after a loading dose of sirolimus. Transplantation. 2003 Jan 15;75(1):86-90. doi: 10.1097/00007890-200301150-00016.
- Background: PubMed 11316866Podder H, Stepkowski SM, Napoli KL, Clark J, Verani RR, Chou TC, Kahan BD. Pharmacokinetic interactions augment toxicities of sirolimus/cyclosporine combinations. J Am Soc Nephrol. 2001 May;12(5):1059-1071. doi: 10.1681/ASN.V1251059.
- Background: PubMed 10221490Groth CG, Backman L, Morales JM, Calne R, Kreis H, Lang P, Touraine JL, Claesson K, Campistol JM, Durand D, Wramner L, Brattstrom C, Charpentier B. Sirolimus (rapamycin)-based therapy in human renal transplantation: similar efficacy and different toxicity compared with cyclosporine. Sirolimus European Renal Transplant Study Group. Transplantation. 1999 Apr 15;67(7):1036-42. doi: 10.1097/00007890-199904150-00017.
- Background: PubMed 11833142MacDonald A. Improving tolerability of immunosuppressive regimens. Transplantation. 2001 Dec 27;72(12 Suppl):S105-12.
- Derived from this study: PubMed 26914542Fleming JN, Taber DJ, Pilch NA, McGillicuddy JW, Srinivas TR, Baliga PK, Chavin KD, Bratton CF. A randomized, prospective comparison of transition to sirolimus-based CNI-minimization or withdrawal in African American kidney transplant recipients. Clin Transplant. 2016 May;30(5):528-33. doi: 10.1111/ctr.12718. Epub 2016 Mar 14.
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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.
Charles Bratton, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rapamune, mycophenolate mofetil and steroid and tacrolimus, sirolimus and steroid in people with Absence; Kidney, run by Medical University of South Carolina 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 9 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 11 Mar 2016. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effectiveness and Safety of a Particular Drug Regimen to Prevent Kidney Rejection (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01005706, which also lists 9 linked publications.
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 11 Mar 2016.