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.
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| ClinicalTrials.gov Identifier: NCT00235300 |
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Recruitment Status :
Completed
First Posted : October 10, 2005
Last Update Posted : March 18, 2015
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Sponsor:
Genzyme, a Sanofi Company
Information provided by:
Sanofi
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Brief 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.
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cadaveric Donor Renal Transplantation Acute Renal Allograft Rejection Induction Therapy | Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)] Drug: Simulect (basliximab) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 240 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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 |
| Study Start Date : | May 2000 |
| Actual Primary Completion Date : | April 2003 |
| Actual Study Completion Date : | June 2005 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Transplantation
Drug Information available for:
Basiliximab
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1 Control
Simulect (basiliximab)
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Drug: Simulect (basliximab)
20 mg per day on 2 days |
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Experimental: 2
Thymoglobulin (anti-thymocyte globulin (rabbit))
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Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)]
1.5 mg/kg per day, for a maximum of 5 doses |
Primary Outcome Measures :
- Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant. [ Time Frame: 6 months ]
Secondary Outcome Measures :
- 12-mo. safety & efficacy assessments including side effects and overall kidney transplant function. [ Time Frame: 12 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235300
Locations
Show 28 study locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
| Study Director: | Medical Monitor | Genzyme, a Sanofi Company |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medical Monitor, Genzyme Corporation |
| ClinicalTrials.gov Identifier: | NCT00235300 |
| Other Study ID Numbers: |
SMC-101-1010 |
| First Posted: | October 10, 2005 Key Record Dates |
| Last Update Posted: | March 18, 2015 |
| Last Verified: | March 2015 |
Keywords provided by Sanofi:
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Anti-T cells antibodies Cadaveric Donor Renal Transplantation Acute Renal Allograft Rejection Induction Therapy |
Additional relevant MeSH terms:
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Delayed Graft Function Pathologic Processes Thymoglobulin Antilymphocyte Serum |
Basiliximab Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents |