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.

• Register: ClinicalTrials.gov
• Last refreshed on: 30 March 2015
• Main ID: NCT00235300
• Date of registration: 06/10/2005
• Prospective Registration: No
• Primary sponsor: Genzyme, a Sanofi Company
• Public title: 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.
• Scientific 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
• Date of first enrolment: May 2000
• Target sample size: 240
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00235300
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

France, Germany, Spain, United Kingdom, United States

Contacts

• Name: Medical Monitor
• Affiliation: Genzyme, a Sanofi Company

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cadaveric Donor Renal Transplantation

Induction Therapy

Acute Renal Allograft Rejection

Intervention(s)

Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)]

Drug: Simulect (basliximab)

Primary Outcome(s)

Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant. [Time Frame: 6 months]

Secondary Outcome(s)

12-mo. safety & efficacy assessments including side effects and overall kidney transplant function. [Time Frame: 12 months]

Secondary ID(s)

SMC-101-1010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors