Renal TransplantationPhase 4NCT00650468
A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients
A Phase 4 study testing tacrolimus, CellCept and steroids (methylprednisone or prednisone) in people with Renal Transplantation, run by Astellas Pharma Inc at 29 sites in United States.
Trial summary
A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- tacrolimus, CellCept and steroids (methylprednisone or prednisone)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 29 sitesUnited States
- Study dates
- Nov 1999to 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
- Patient is between post kidney transplant day 3-7 and no requirement for dialysis
Who cannot join
- Patient is receiving kidney from HLA identical,living donor
- Patient is a multi-organ transplant recipient
- Patient is pregnant or lactating. Female patients of child bering potential must have a negative pregnancy test and agree to practice effective birth control
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Study site
Baltimore, Maryland, 21201
Study site
Boston, Massachusetts, 02111
Study site
Buffalo, New York, 14203
Study site
Chicago, Illinois, 60637
Study site
Cincinnati, Ohio, 45267
Study site
Cleveland, Ohio, 44106
Study site
Denver, Colorado, 80262
Study site
Detroit, Michigan, 48202
Study site
Galveston, Texas, 77555
Study site
Lexington, Kentucky, 40536
Study site
Little Rock, Arkansas, 72205
Study site
Loma Linda, California, 92354
Study site
Los Angeles, California, 90057
Study site
Madison, Wisconsin, 53792
Study site
Memphis, Tennessee, 38163
Study site
Milwaukee, Wisconsin, 53226
Study site
Minneapolis, Minnesota, 55455
Study site
Nashville, Tennessee, 37232
Study site
New Brunswick, New Jersey, 08903
Study site
New Orleans, Louisiana, 70121
Study site
New York, New York, 10021
Study site
New York, New York, 10029
Study site
Omaha, Nebraska, 68198
Study site
Philadelphia, Pennsylvania, 19107
Study site
Providence, Rhode Island, 02903
Study site
Rochester, Minnesota, 55905
Study site
Salt Lake City, Utah, 84103
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78229
About this study
Official title: A Prospective, Randomized, Multi-Center Double-Blind Study of Early Corticosteroid Cessation vs. Long Term Corticosteroid Therapy With Prograf and CellCept in Primary Renal Transplant Patients
A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept
- Conditions
- Renal Transplantation
- Being tested
- tacrolimus, CellCept, steroids (methylprednisone or prednisone)
- Keywords
- Renal Transplantation, Prograf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
Also called Prograf, FK506
Oral
CellCeptDrug
Also called MMF, Mycophenolate mofetil
IV or Oral
steroids (methylprednisone or prednisone)Drug
Also called methylprednisone, prednisone
IV or Oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | early steroid cessation Receives: Drug: tacrolimus; Drug: CellCept; Drug: steroids (methylprednisone or prednisone) |
| 2 | Experimental | long-term maintenance steroids Receives: Drug: tacrolimus; Drug: CellCept; Drug: steroids (methylprednisone or prednisone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of death, graft loss, or severe acute rejection
Measured: 6 months, 12 months, yearly up to 5 years
Secondary outcomes (5)
Comparison of patient and graf survival
Measured: 6 months, 12 months, yearly up to 5 years
Incidence and severity of acute rejection
Measured: 6 months, 12 months, yearly up to 5 years
Need for antilymphocyte treatment
Measured: 6 months, 12 months, yearly up to 5 years
Graft function
Measured: 6 month, 12 months, yearly up to 5 years
Framingham Coronary Heart Disease Risk Factors
Measured: 6 months, 12 months, yearly up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startNov 1999
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- central contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650468
- Sponsor's protocol ID
- 20-99-001
- Status last verified
- Mar 2009
- First submitted
- 17 Mar 2008
- Last updated
- 17 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Woodle ES; Fujisawa Corticosteroid Withdrawal Study Group. A prospective, randomized, multicenter, double-blind study of early corticosteroid cessation versus long-term maintenance of corticosteroid therapy with tacrolimus and mycophenolate mofetil in primary renal transplant recipients: one year report. Transplant Proc. 2005 Mar;37(2):804-8. doi: 10.1016/j.transproceed.2004.12.083.
PubMed 15848538Woodle ES, First MR, Pirsch J, Shihab F, Gaber AO, Van Veldhuisen P; Astellas Corticosteroid Withdrawal Study Group. A prospective, randomized, double-blind, placebo-controlled multicenter trial comparing early (7 day) corticosteroid cessation versus long-term, low-dose corticosteroid therapy. Ann Surg. 2008 Oct;248(4):564-77. doi: 10.1097/SLA.0b013e318187d1da.
PubMed 18936569Gaber AO, Moore LW, Alloway RR, Woodle ES, Pirsch J, Shihab F, Henning A, Fitzsimmons W, Holman J, Reisfield R, First MR; Astellas Corticosteroid Withdrawal Study Group. Acute rejection characteristics from a prospective, randomized, double-blind, placebo-controlled multicenter trial of early corticosteroid withdrawal. Transplantation. 2013 Feb 27;95(4):573-9. doi: 10.1097/TP.0b013e3182777efb.
PubMed 23423269Delgado JC, Fuller A, Ozawa M, Smith L, Terasaki PI, Shihab FS, Eckels DD. No occurrence of de novo HLA antibodies in patients with early corticosteroid withdrawal in a 5-year prospective randomized study. Transplantation. 2009 Feb 27;87(4):546-8. doi: 10.1097/TP.0b013e3181949d2e.
PubMed 19307792
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-Center Double-Blind Study of Early Corticosteroid Cessation vs. Long Term Corticosteroid Therapy With Prograf and CellCept in Primary Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT00650468
- Acronym / sponsor ID
- 20-99-001
- Conditions
- Renal Transplantation
- Keywords
- Renal Transplantation, Prograf
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Nov 1999
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 1 Apr 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.
A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tacrolimus, Drug: CellCept, Drug: steroids (methylprednisone or prednisone)early steroid cessation |
| 2 | Experimental | Drug: tacrolimus, Drug: CellCept, Drug: steroids (methylprednisone or prednisone)long-term maintenance steroids |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient is between post kidney transplant day 3-7 and no requirement for dialysis
Key exclusion criteria (3 listed)
- Patient is receiving kidney from HLA identical,living donor
- Patient is a multi-organ transplant recipient
- Patient is pregnant or lactating. Female patients of child bering potential must have a negative pregnancy test and agree to practice effective 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 |
|---|---|---|
| tacrolimusAlso: Prograf, FK506Oral | Drug | 1, 2 |
| CellCeptAlso: MMF, Mycophenolate mofetilIV or Oral | Drug | 1, 2 |
| steroids (methylprednisone or prednisone)Also: methylprednisone, prednisoneIV or Oral | Drug | 1, 2 |
Primary outcome
Assessment of death, graft loss, or severe acute rejection
Time frame: 6 months, 12 months, yearly up to 5 years
5 secondary outcomes
Comparison of patient and graf survival
Time frame: 6 months, 12 months, yearly up to 5 years
Incidence and severity of acute rejection
Time frame: 6 months, 12 months, yearly up to 5 years
Need for antilymphocyte treatment
Time frame: 6 months, 12 months, yearly up to 5 years
Graft function
Time frame: 6 month, 12 months, yearly up to 5 years
Framingham Coronary Heart Disease Risk Factors
Time frame: 6 months, 12 months, yearly up to 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 17 Nov 2011.
- Background: PubMed 15848538Woodle ES; Fujisawa Corticosteroid Withdrawal Study Group. A prospective, randomized, multicenter, double-blind study of early corticosteroid cessation versus long-term maintenance of corticosteroid therapy with tacrolimus and mycophenolate mofetil in primary renal transplant recipients: one year report. Transplant Proc. 2005 Mar;37(2):804-8. doi: 10.1016/j.transproceed.2004.12.083.
- Background: PubMed 18936569Woodle ES, First MR, Pirsch J, Shihab F, Gaber AO, Van Veldhuisen P; Astellas Corticosteroid Withdrawal Study Group. A prospective, randomized, double-blind, placebo-controlled multicenter trial comparing early (7 day) corticosteroid cessation versus long-term, low-dose corticosteroid therapy. Ann Surg. 2008 Oct;248(4):564-77. doi: 10.1097/SLA.0b013e318187d1da.
- Derived from this study: PubMed 23423269Gaber AO, Moore LW, Alloway RR, Woodle ES, Pirsch J, Shihab F, Henning A, Fitzsimmons W, Holman J, Reisfield R, First MR; Astellas Corticosteroid Withdrawal Study Group. Acute rejection characteristics from a prospective, randomized, double-blind, placebo-controlled multicenter trial of early corticosteroid withdrawal. Transplantation. 2013 Feb 27;95(4):573-9. doi: 10.1097/TP.0b013e3182777efb.
- Derived from this study: PubMed 19307792Delgado JC, Fuller A, Ozawa M, Smith L, Terasaki PI, Shihab FS, Eckels DD. No occurrence of de novo HLA antibodies in patients with early corticosteroid withdrawal in a 5-year prospective randomized study. Transplantation. 2009 Feb 27;87(4):546-8. doi: 10.1097/TP.0b013e3181949d2e.
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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.
central contact study director
Astellas Pharma US, Inc.
29 sites 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, CellCept and steroids (methylprednisone or prednisone) in people with Renal Transplantation, run by Astellas Pharma Inc at 29 sites 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 1 inclusion and 3 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 17 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites 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?
Assessment of death, graft loss, or severe acute rejection (time frame: 6 months, 12 months, yearly up to 5 years). 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 NCT00650468, which also lists 4 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 17 Nov 2011; AzTrials last refreshed its copy on 4 Nov 2026.