Adult Primary Kidney TransplantationPhase 4NCT00681213
Tacrolimus/Sirolimus Versus Tacrolimus/Mycophenolate Mofetil (MMF) Versus Neoral/Sirolimus in Adult, Primary Kidney Transplantation
A Phase 4 study testing Tacrolimus/Sirolimus, Tacrolimus/MMF and Neoral/Sirolimus in people with Adult Primary Kidney Transplantation, run by University of Miami at 1 site in United States.
Trial summary
Comparison of outcomes/safety/and tolerability of SRL/FK/Pred vs. FK/MMF/Pred vs. SRL/Neoral®/Pred in cadaveric and non-HLA identical LRD kidney transplants. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Adult Primary Kidney Transplantation
- What is being tested?
- Tacrolimus/Sirolimus, Tacrolimus/MMF and Neoral/Sirolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2000to Dec 2002
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >14 years
- Weight > 40 kg
- Primary renal allograft: cadaveric or mismatched living donor
- Negative standard cross match for T-cells
- Women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception throughout the study period and for 3 months after discontinuation of study medication (3yrs, 3 mos.)
- Signed and dated informed consent (Parent or legal guardian must provide written consent for patients <18 years of age)
Who cannot join
- Evidence of systemic infection
- History of malignancy within 10 years (with the exception of localized skin cancer)
- Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase
- Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole
- Known hypersensitivity to sirolimus and its derivatives
- Patients with a screening/baseline (or within 96 hours of transplant)
Show all 12Show fewer
- total white blood cell count < 4000/mm3;
- platelet count < 100,000/mm3;
- fasting triglycerides > 400 mg/dl (> 4.6 mmol/L);
- fasting total cholesterol > 300 mg/dl (> 7.8 mmol/L);
- fasting HDL-cholesterol < 30 mg/dl;
- fasting LDL-cholesterol > 200mg/dl
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Division of Transplantation
Miami, Florida, 33136
About this study
Official title: Tacrolimus and Mycophenolate Versus Tacrolimus and Sirolimus vs. Neoral and Sirolimus Used in Combination in Cadaver and Non-HLA Identical Living Related Kidney Transplants
Comparison of outcomes/safety/and tolerability of SRL/FK/Pred vs. FK/MMF/Pred vs. SRL/Neoral®/Pred in cadaveric and non-HLA identical LRD kidney transplants.
- Conditions
- Adult Primary Kidney Transplantation
- Being tested
- Tacrolimus/Sirolimus, Tacrolimus/MMF, Neoral/Sirolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus/SirolimusDrug
Tacrolimus/MMFDrug
Neoral/SirolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Tacrolimus/Sirolimus Receives: Drug: Tacrolimus/Sirolimus |
| B | Experimental | Tacrolimus/MMF Receives: Drug: Tacrolimus/MMF |
| C | Experimental | Neoral/Sirolimus Receives: Drug: Neoral/Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of acute rejection episodes
Measured: 1 year
Secondary outcomes (1)
1. Graft loss 2. Renal function as determined by serum creatinine and calculated creatinine clearance (using the Cockcroft-Gault method) six and 12 months
Measured: 1, 3, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startMay 2000
- Primary completionDec 2001
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Adult Primary Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth-Ayesrst Pharmaceuticals, Roche Laboratories, and Fujusawa Healthcare, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681213
- Sponsor's protocol ID
- IRB#19990664
- Status last verified
- Sep 2023
- First submitted
- 19 May 2008
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ciancio G, Burke GW, Gaynor JJ, Mattiazzi A, Roth D, Kupin W, Nicolas M, Ruiz P, Rosen A, Miller J. A randomized long-term trial of tacrolimus and sirolimus versus tacrolimus and mycophenolate mofetil versus cyclosporine (NEORAL) and sirolimus in renal transplantation. I. Drug interactions and rejection at one year. Transplantation. 2004 Jan 27;77(2):244-51. doi: 10.1097/01.TP.0000101290.20629.DC.
PubMed 14742989Ciancio G, Burke GW, Gaynor JJ, Mattiazzi A, Roth D, Kupin W, Nicolas M, Ruiz P, Rosen A, Miller J. A randomized long-term trial of tacrolimus/sirolimus versus tacrolimus/mycophenolate mofetil versus cyclosporine (NEORAL)/sirolimus in renal transplantation. II. Survival, function, and protocol compliance at 1 year. Transplantation. 2004 Jan 27;77(2):252-8. doi: 10.1097/01.TP.0000101495.22734.07.
PubMed 14742990Ciancio G, Burke GW, Gaynor JJ, Ruiz P, Roth D, Kupin W, Rosen A, Miller J. A randomized long-term trial of tacrolimus/sirolimus versus tacrolimums/mycophenolate versus cyclosporine/sirolimus in renal transplantation: three-year analysis. Transplantation. 2006 Mar 27;81(6):845-52. doi: 10.1097/01.tp.0000203894.53714.27.
PubMed 16570006Oliveras L, Lopez-Vargas P, Melilli E, Codina S, Royuela A, Coloma Lopez A, Fava A, Manonelles A, Couceiro C, Lloberas N, Cruzado JM, Montero N. Delayed initiation or reduced initial dose of calcineurin-inhibitors for kidney transplant recipients at high risk of delayed graft function. Cochrane Database Syst Rev. 2025 Apr 8;4(4):CD014855. doi: 10.1002/14651858.CD014855.pub2.
PubMed 40197799Ciancio G, Gaynor JJ, Sageshima J, Roth D, Kupin W, Guerra G, Tueros L, Zarak A, Hanson L, Ganz S, Chen L, Ruiz P, Livingstone AS, Burke GW 3rd. Machine perfusion following static cold storage preservation in kidney transplantation: donor-matched pair analysis of the prognostic impact of longer pump time. Transpl Int. 2012 Jan;25(1):34-40. doi: 10.1111/j.1432-2277.2011.01364.x. Epub 2011 Oct 8.
PubMed 21981661
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tacrolimus and Mycophenolate Versus Tacrolimus and Sirolimus vs. Neoral and Sirolimus Used in Combination in Cadaver and Non-HLA Identical Living Related Kidney Transplants
- ClinicalTrials.gov ID
- NCT00681213
- Acronym / sponsor ID
- IRB#19990664
- Conditions
- Adult Primary Kidney Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Wyeth-Ayesrst Pharmaceuticals, Roche Laboratories, and Fujusawa Healthcare, Inc.
- Study start
- May 2000
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 21 May 2008 (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.
Comparison of outcomes/safety/and tolerability of SRL/FK/Pred vs. FK/MMF/Pred vs. SRL/Neoral®/Pred in cadaveric and non-HLA identical LRD kidney transplants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Tacrolimus/SirolimusTacrolimus/Sirolimus |
| B | Experimental | Drug: Tacrolimus/MMFTacrolimus/MMF |
| C | Experimental | Drug: Neoral/SirolimusNeoral/Sirolimus |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age >14 years
- Weight > 40 kg
- Primary renal allograft: cadaveric or mismatched living donor
- Negative standard cross match for T-cells
- Women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception throughout the study period and for 3 months after discontinuation of study medication (3yrs, 3 mos.)
Key exclusion criteria (12 listed)
- Evidence of systemic infection
- History of malignancy within 10 years (with the exception of localized skin cancer)
- Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase
- Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole
- Known hypersensitivity to sirolimus and its derivatives
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 |
|---|---|---|
| Tacrolimus/Sirolimus | Drug | A |
| Tacrolimus/MMF | Drug | B |
| Neoral/Sirolimus | Drug | C |
Primary outcome
Incidence and severity of acute rejection episodes
Time frame: 1 year
1 secondary outcome
1. Graft loss 2. Renal function as determined by serum creatinine and calculated creatinine clearance (using the Cockcroft-Gault method) six and 12 months
Time frame: 1, 3, and 5 years
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 22 Sep 2023.
- Results publication: PubMed 14742989Ciancio G, Burke GW, Gaynor JJ, Mattiazzi A, Roth D, Kupin W, Nicolas M, Ruiz P, Rosen A, Miller J. A randomized long-term trial of tacrolimus and sirolimus versus tacrolimus and mycophenolate mofetil versus cyclosporine (NEORAL) and sirolimus in renal transplantation. I. Drug interactions and rejection at one year. Transplantation. 2004 Jan 27;77(2):244-51. doi: 10.1097/01.TP.0000101290.20629.DC.
- Results publication: PubMed 14742990Ciancio G, Burke GW, Gaynor JJ, Mattiazzi A, Roth D, Kupin W, Nicolas M, Ruiz P, Rosen A, Miller J. A randomized long-term trial of tacrolimus/sirolimus versus tacrolimus/mycophenolate mofetil versus cyclosporine (NEORAL)/sirolimus in renal transplantation. II. Survival, function, and protocol compliance at 1 year. Transplantation. 2004 Jan 27;77(2):252-8. doi: 10.1097/01.TP.0000101495.22734.07.
- Results publication: PubMed 16570006Ciancio G, Burke GW, Gaynor JJ, Ruiz P, Roth D, Kupin W, Rosen A, Miller J. A randomized long-term trial of tacrolimus/sirolimus versus tacrolimums/mycophenolate versus cyclosporine/sirolimus in renal transplantation: three-year analysis. Transplantation. 2006 Mar 27;81(6):845-52. doi: 10.1097/01.tp.0000203894.53714.27.
- Derived from this study: PubMed 40197799Oliveras L, Lopez-Vargas P, Melilli E, Codina S, Royuela A, Coloma Lopez A, Fava A, Manonelles A, Couceiro C, Lloberas N, Cruzado JM, Montero N. Delayed initiation or reduced initial dose of calcineurin-inhibitors for kidney transplant recipients at high risk of delayed graft function. Cochrane Database Syst Rev. 2025 Apr 8;4(4):CD014855. doi: 10.1002/14651858.CD014855.pub2.
- Derived from this study: PubMed 21981661Ciancio G, Gaynor JJ, Sageshima J, Roth D, Kupin W, Guerra G, Tueros L, Zarak A, Hanson L, Ganz S, Chen L, Ruiz P, Livingstone AS, Burke GW 3rd. Machine perfusion following static cold storage preservation in kidney transplantation: donor-matched pair analysis of the prognostic impact of longer pump time. Transpl Int. 2012 Jan;25(1):34-40. doi: 10.1111/j.1432-2277.2011.01364.x. Epub 2011 Oct 8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tacrolimus/Sirolimus, Tacrolimus/MMF and Neoral/Sirolimus in people with Adult Primary Kidney Transplantation, run by University of Miami 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 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: finished, as of the sponsor's last update on 22 Sep 2023. 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 and severity of acute rejection episodes (time frame: 1 year). 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 NCT00681213, which also lists 5 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 22 Sep 2023.