Kidney TransplantPhase 3NCT00137345
Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients
A Phase 3 study testing sirolimus in people with Kidney Transplant, run by Wyeth is now a wholly owned subsidiary of Pfizer at 82 sites in 21 countries.
Trial summary
The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- sirolimus
- How many people
- 500 participants
- Where
- 82 sitesin 21 countries
- Study dates
- Jun 2005to Aug 2006
- Phase
- Phase 3
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Dialysis patients who will be receiving their first kidney transplant
- Weight over 88 pounds (lbs.)
Who cannot join
- Very high cholesterol levels
- Obesity
- Organ donor over 65 years of age if living; over 60 years of age if cadaveric.
Trial locations and contacts
82 sites in 21 countries.
82 sites in 21 countries
United States23 sites
Study site
Atlanta, Georgia, 30309
Study site
Charleston, South Carolina, 29425
Study site
Charlotte, North Carolina, 28203
Study site
Chicago, Illinois, 60612-3824
Study site
Cleveland, Ohio, 44106
Study site
Cleveland, Ohio, 44195
Study site
Dallas, Texas, 75246
Study site
Denver, Colorado, 80262
Study site
Detroit, Michigan, 48202
Study site
Durham, North Carolina, 27710
Study site
Gainesville, Florida, 32610
Study site
Houston, Texas, 77225
Study site
New Haven, Connecticut, 06520
Study site
New York, New York, 10029
Study site
Philadelphia, Pennsylvania, 19107
Study site
Philadelphia, Pennsylvania, 19129
Study site
Portland, Maine, 04102
Study site
Providence, Rhode Island
Study site
San Diego, California, 92123
Study site
San Francisco, California, 94143
Study site
Springfield, Massachusetts, 01199
Study site
Tampa, Florida, 33606
Study site
Toledo, Ohio, 43614
Argentina9 sites
Study site
Buenos Aires, Capital Ferderal, 1093
Study site
Buenos Aires, Capital Ferderal, 1155
Study site
Buenos Aires, Capital Ferderal, 1425
Study site
Buenos Aires, Capital Ferderal, C1118AT
Study site
Buenos Aires, Capital Ferderal, C1425APQ
Study site
Buenos Aires, CP1900
Study site
Ciudad de Bs As
Study site
Córdoba, 5000
Study site
Córdoba
Spain7 sites
Study site
Barcelona, 08036
Study site
La Coruã'a, 15006
Study site
La Laguna / Santa Cruz de Tenerife, 38320
Study site
Madrid, 28040
Study site
Madrid, 28041
Study site
Santander, 39008
Study site
Valencia, 46009
Australia6 sites
Study site
Camperdown, NSW 2050
Study site
Parkville, 3050
Study site
Randwick, 2031
Study site
Westmead, 2145
Study site
Woodville South, SA 5011
Study site
Woolloongabba, QLD 4102
Chile4 sites
Study site
Puente Alto
Study site
Santiago
Study site
Talca
Study site
Viña del Mar
Hungary4 sites
Study site
Budapest, 1083
Study site
Debrecen, 4012
Study site
Pécs, 7621
Study site
Szeged, 6720
Canada3 sites
Study site
Cote Du Palais, Quebec, G1R 2J6
Study site
London, Ontario, N6A 5A5
Study site
Montreal, Quebec, H2L 4M1
Italy3 sites
Study site
Bari, 70124
Study site
Cagliari, 09134
Study site
Torino, 10126
Portugal3 sites
Study site
Carnaxide-lisboa, 2795-563
Study site
Coimbra, 3049
Study site
Lisbon, 81050
South Africa3 sites
Study site
Cape Town, 7925
Study site
Cape Town, 8001
Study site
Johannesburg, 2193
Turkey (Türkiye)3 sites
Study site
Antalya, 07070
Study site
Istanbul, 34390
Study site
Izmir, 35100
United Kingdom3 sites
Study site
Glasgow, G11 6NT
Study site
Leicester, LE5 4PW
Study site
Manchester, M13 9WL
About this study
Official title: A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus Versus Cyclosporine When Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients
The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.
- Conditions
- Kidney Transplant
- Being tested
- sirolimus
- Keywords
- Randomized controlled trial, Clinical Trial Phase III, Drug therapy, Immunosuppression, Treatment outcome, Kidney transplantation, Kidney function tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR)
Non-inferiority of the composite of graft loss and death at 52 weeks
Secondary outcomes (2)
Incidence and severity of rejection at 12, 24, 52, 104, 156, 208 weeks; GFR at 24, 104, 156, 208 weeks; progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weeks
quality of life at 24, 52 and 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startJun 2005
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For Germany, MedInfoDEU@wyeth.comTrial Manager, Principal investigator, For Norway, Sweden, MedInfoNord@wyeth.comTrial Manager, Principal investigator, For Australia, Taiwan, medinfo@wyeth.comTrial Manager, Principal investigator, For Austria, WPVIMED@wyeth.comTrial Manager, Principal investigator, For Italy, Greece, decresg@wyeth.comTrial manager, Principal investigator, For Hungary, WPBUMED@wyeth.comTrial Manager, Principal investigator, For Turkey, Erisc@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137345
- Sponsor's protocol ID
- 0468H1-318
- Other IDs
- B1741188
- Status last verified
- Sep 2006
- First submitted
- 25 Aug 2005
- Last updated
- 8 Feb 2013
- Results posted
- No
Publications
Flechner SM, Gurkan A, Hartmann A, Legendre CM, Russ GR, Campistol JM, Schena FP, Hahn CM, Li H, Korth-Bradley JM, Tai SS, Schulman SL. A randomized, open-label study of sirolimus versus cyclosporine in primary de novo renal allograft recipients. Transplantation. 2013 May 27;95(10):1233-41. doi: 10.1097/TP.0b013e318291a269.
PubMed 23689085
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus Versus Cyclosporine When Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients
- ClinicalTrials.gov ID
- NCT00137345
- Acronym / sponsor ID
- 0468H1-318
- Conditions
- Kidney Transplant
- Keywords
- Randomized controlled trial, Clinical Trial Phase III, Drug therapy, Immunosuppression, Treatment outcome, Kidney transplantation, Kidney function tests
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 500 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 29 Aug 2005 (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 determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Dialysis patients who will be receiving their first kidney transplant
- Weight over 88 pounds (lbs.)
Key exclusion criteria (3 listed)
- Very high cholesterol levels
- Obesity
- Organ donor over 65 years of age if living; over 60 years of age if cadaveric.
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 |
|---|---|---|
| sirolimus | Drug | – |
Primary outcome
To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR)
Non-inferiority of the composite of graft loss and death at 52 weeks
2 secondary outcomes
Incidence and severity of rejection at 12, 24, 52, 104, 156, 208 weeks; GFR at 24, 104, 156, 208 weeks; progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weeks
quality of life at 24, 52 and 104 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
- Derived from this study: PubMed 23689085Flechner SM, Gurkan A, Hartmann A, Legendre CM, Russ GR, Campistol JM, Schena FP, Hahn CM, Li H, Korth-Bradley JM, Tai SS, Schulman SL. A randomized, open-label study of sirolimus versus cyclosporine in primary de novo renal allograft recipients. Transplantation. 2013 May 27;95(10):1233-41. doi: 10.1097/TP.0b013e318291a269.
Related trials for Kidney Transplant
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager principal investigator
For Germany, MedInfoDEU@wyeth.com
Trial Manager principal investigator
For Norway, Sweden, MedInfoNord@wyeth.com
82 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sirolimus in people with Kidney Transplant, run by Wyeth is now a wholly owned subsidiary of Pfizer at 82 sites in 21 countries.
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 2 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: stopped early, as of the sponsor's last update on 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States, Argentina, Spain, Australia, Chile and 16 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR). The study lists 2 primary outcomes in all. 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 NCT00137345, which also lists 1 linked publication.
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 8 Feb 2013.