Cadaveric Donor Renal TransplantationPhase 2NCT00235300
An Open-label, Prospective, Randomized, Multi-center, Phase II Comparative Trial of Thymoglobulin Versus Simulect for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients.
A Phase 2 study testing Thymoglobulin [Anti-thymocyte Globulin (rabbit)] and Simulect (basliximab) in people with Cadaveric Donor Renal Transplantation and Acute Renal Allograft Rejection, run by Genzyme, a Sanofi Company at 28 sites in 5 countries.
Trial summary
A multicenter clinical study comparing event-free survival at 6 months after transplant between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients. Patients received Thymoglobulin or Simulect from Day 0 through Day 4. Day 0 was considered the day of the transplant procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cadaveric Donor Renal Transplantation, Acute Renal Allograft Rejection, Induction Therapy
- What is being tested?
- Thymoglobulin [Anti-thymocyte Globulin (rabbit)] and Simulect (basliximab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 28 sitesin 5 countries
- Study dates
- May 2000to Jun 2005
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient greater than or equal to 18 years old.
- Patient is classified as "high risk" for acute allograft rejection of DGF. Must have had at least 1 donor or 1 recipient variable for high risk.
- Patient will be a recipient of a solitary cadaveric renal allograft.
- Women of childbearing potential must have had a negative pregnancy test (serum or urine).
- Man or woman agrees to practice medically acceptable contraception (i.e. barrier or pharmacologic) for a minimum of 3 months following study drug administration. In addition, women were recommended to practice contraception for 1 year following transplantation, or per local standard.
- Patient agrees to participate in the study and sign an informed consent.
- Patient has no known contraindication to the administration of rabbit anti-thymocyte globulin or basiliximab. Patient has no history of hypersensitivity to basiliximab.
- Patient is dialysis-dependent at the time immediately prior to transplantation.
Who cannot join
- Patient has received an investigational medication within the past 30 days.
- Patient has a history of malignancy within 2 years, with the exception of adequately treated localized squamous basal cell carcinoma of the skin without evidence of recurrence.
- Patient is currently abusing drugs or alcohol.
- Patient is known or suspected to have an active infection or be seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency virus (HIV).
- Patient is a multiple organ transplant recipient.
- Patient is on any type of immunosuppression (i.e. prior transplant recipient still on immunosuppression, or patient is receiving systemic steroids for any medical condition).
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- Patient, who, in the opinion of the investigator, has significant medical or psychosocial problems or unstable disease states which would preclude enrollment. Examples of significant medical problems include, but are not limited to, morbid obesity or severe cardiac disease.
- Kidneys that are to be implanted en bloc or from donors less than 6 years old.
- Kidneys from donors that are known or suspected to have an active infection with or be seropositive for HBsAg, hepatitis B core antibody (HBcAb), HCV, or HIV.
- Kidneys from donors that have received investigational therapies designed to reduce the impact of ischemia reperfusion, DGF, or other donor-related immune events.
- Donor kidney is preserved by cold storage (with or without machine preservation) for less than 16 hours, with the exception of kidneys from non-heart-beating donors or kidneys from donors greater than 50 years old or donors with a SCr above 2.5mg/dL.
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
United States16 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30322
Medical College of Georgia
Augusta, Georgia, 30912
University of Alabama
Birmingham, Alabama, 35296
Carolinas Medical Center
Charlotte, North Carolina, 28232
Rush University Transplant Program
Chicago, Illinois, 60612
University of Texas Medical Branch
Galveston, Texas, 77555
University of Kentucky Medical Center
Lexington, Kentucky, 40536
St. Barnabas Medical Center
Livingston, New Jersey, 07039
UCLA School of Medicine
Los Angeles, California, 90095
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Yale University School of Medicine
New Haven, Connecticut, 06510
Florida Hospital Medical Center and Translife
Orlando, Florida, 32804
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
California Pacific Medical Center
San Francisco, California, 94115
Westchester Medical Center
Valhalla, New York, 10595
France5 sites
Hopital Saint Jacques
Besançon, 25000
Hopital de Bradois
Cedex, 54511
Centre Hospitalier Universitaire
Grenoble, 38043
Hopital Edouard Herriot
Lyon, 59003
Hopital Foch
Suresnes, 92151
Spain4 sites
Hospital de Cruces
Barakaldo
Hospital Clinico Universitario
Barcelona, 08036
Hospital Reina Sofia
Córdoba, 14004
Hospital Occe de Octubre
Madrid, 28041
Germany2 sites
Unicersitat Erlangen-Numberg
Erlangen, 12 91054
University Hospital Eppendorf
Hamburg, 52 20246
About this study
Official title: An Open-Label Prospective, Randomized, Multicenter Phase II Comparative Trial of Thymoglobulin® Versus Simulect® for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients
A multicenter clinical study comparing event-free survival at 6 months after transplant between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients. Patients received Thymoglobulin or Simulect from Day 0 through Day 4. Day 0 was considered the day of the transplant procedure.
Subjects meeting all inclusion and exclusion criteria were eligible to participate in this study. The treatment assignment was random and not chosen by the subject or their physician.
Read more
Subjects were monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurred up to 12 months after transplant.
278 study subjects were enrolled at 28 transplant centers in the United States and Europe.
- Being tested
- Thymoglobulin [Anti-thymocyte Globulin (rabbit)], Simulect (basliximab)
- Keywords
- Anti-T cells antibodies, Cadaveric Donor Renal Transplantation, Acute Renal Allograft Rejection, Induction Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymoglobulin [Anti-thymocyte Globulin (rabbit)]Biological
1.5 mg/kg per day, for a maximum of 5 doses
Simulect (basliximab)Drug
20 mg per day on 2 days
| Study group | Role | What they receive |
|---|---|---|
| 1 Control | Active comparator | Simulect (basiliximab) Receives: Drug: Simulect (basliximab) |
| 2 | Experimental | Thymoglobulin (anti-thymocyte globulin (rabbit)) Receives: Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant.
Measured: 6 months
Secondary outcomes (1)
12-mo. safety & efficacy assessments including side effects and overall kidney transplant function.
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 posted10 Oct 2005 (estimated)
- Study startMay 2000
- Primary completionApr 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cadaveric Donor 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235300
- Sponsor's protocol ID
- SMC-101-1010
- Status last verified
- Mar 2015
- First submitted
- 6 Oct 2005
- Last updated
- 18 Mar 2015
- Results posted
- No
Publications
Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D; Thymoglobulin Induction Study Group. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006 Nov 9;355(19):1967-77. doi: 10.1056/NEJMoa060068.
PubMed 17093248Lentine KL, Schnitzler MA, Xiao H, Brennan DC. Long-term safety and efficacy of antithymocyte globulin induction: use of integrated national registry data to achieve ten-year follow-up of 10-10 Study participants. Trials. 2015 Aug 19;16:365. doi: 10.1186/s13063-015-0891-y.
PubMed 26285695
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Prospective, Randomized, Multicenter Phase II Comparative Trial of Thymoglobulin® Versus Simulect® for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients
- ClinicalTrials.gov ID
- NCT00235300
- Acronym / sponsor ID
- SMC-101-1010
- Keywords
- Anti-T cells antibodies, Cadaveric Donor Renal Transplantation, Acute Renal Allograft Rejection, Induction Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Apr 2003 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 10 Oct 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.
A multicenter clinical study comparing event-free survival at 6 months after transplant between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients. Patients received Thymoglobulin or Simulect from Day 0 through Day 4. Day 0 was considered the day of the transplant procedure.
Subjects meeting all inclusion and exclusion criteria were eligible to participate in this study. The treatment assignment was random and not chosen by the subject or their physician.
Subjects were monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurred up to 12 months after transplant.
278 study subjects were enrolled at 28 transplant centers in the United States and Europe.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Control | Active comparator | Drug: Simulect (basliximab)Simulect (basiliximab) |
| 2 | Experimental | Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)]Thymoglobulin (anti-thymocyte globulin (rabbit)) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient greater than or equal to 18 years old.
- Patient is classified as "high risk" for acute allograft rejection of DGF. Must have had at least 1 donor or 1 recipient variable for high risk.
- Patient will be a recipient of a solitary cadaveric renal allograft.
- Women of childbearing potential must have had a negative pregnancy test (serum or urine).
- Man or woman agrees to practice medically acceptable contraception (i.e. barrier or pharmacologic) for a minimum of 3 months following study drug administration. In addition, women were recommended to practice contraception for 1 year following transplantation, or per local standard.
Key exclusion criteria (11 listed)
- Patient has received an investigational medication within the past 30 days.
- Patient has a history of malignancy within 2 years, with the exception of adequately treated localized squamous basal cell carcinoma of the skin without evidence of recurrence.
- Patient is currently abusing drugs or alcohol.
- Patient is known or suspected to have an active infection or be seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency virus (HIV).
- Patient is a multiple organ transplant recipient.
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 |
|---|---|---|
| Thymoglobulin [Anti-thymocyte Globulin (rabbit)]1.5 mg/kg per day, for a maximum of 5 doses | Biological | 2 |
| Simulect (basliximab)20 mg per day on 2 days | Drug | 1 Control |
Primary outcome
Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant.
Time frame: 6 months
1 secondary outcome
12-mo. safety & efficacy assessments including side effects and overall kidney transplant function.
Time frame: 12 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 18 Mar 2015.
- Results publication: PubMed 17093248Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D; Thymoglobulin Induction Study Group. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006 Nov 9;355(19):1967-77. doi: 10.1056/NEJMoa060068.
- Derived from this study: PubMed 26285695Lentine KL, Schnitzler MA, Xiao H, Brennan DC. Long-term safety and efficacy of antithymocyte globulin induction: use of integrated national registry data to achieve ten-year follow-up of 10-10 Study participants. Trials. 2015 Aug 19;16:365. doi: 10.1186/s13063-015-0891-y.
- US FDA Approved Full Prescribing Information for Thymoglobulin®Link provided by the sponsor.
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
Genzyme, a Sanofi Company
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thymoglobulin [Anti-thymocyte Globulin (rabbit)] and Simulect (basliximab) in people with Cadaveric Donor Renal Transplantation and Acute Renal Allograft Rejection, run by Genzyme, a Sanofi Company at 28 sites in 5 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 8 inclusion and 11 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 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, France, Spain, Germany, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant. (time frame: 6 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 NCT00235300, which also lists 2 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 18 Mar 2015.