Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant (Simulect)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00928811
Recruitment Status : Terminated (Investigator left University 04/2010)
First Posted : June 26, 2009
Last Update Posted : February 10, 2015
Information provided by (Responsible Party):
cynthia gifford, Drexel University

Brief Summary:
The study is undertaken to explore the safety of using Simulect at monthly dose intervals to reduce the need of high dose/level CNI's such as Prograf.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: basiliximab Phase 2 Phase 3

Detailed Description:
The use of CNI's after kidney transplantation is associated with typical adverse effects such as potential contribution to progressive impairment of renal function, hypertension, and metabolic abnormalities. The study consists of a run-in phase (1 month),and treatment phase (11 months) and safety assessment phase (1 month).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: One-year Exploratory Study to Evaluate the Safety of Partial Replacement of CNI With Chronic Administration of Simulect in de Novo Normal-risk Kidney Transplant Recipients Treated With MPA
Study Start Date : May 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Basiliximab

Arm Intervention/treatment
Standard of care administration with Simulect (basiliximab)being administered as per induction therapy on day of transplant and day 4.
Drug: basiliximab
Simulect 20 mg intravenously day of transplant and day 4
Other Name: Simulect

Experimental: Simulect

Simulect (basiliximab) intravenously day of transplant and day 4.

Chronic Simulect (basiliximab) administration monthly for one year duration.

Concomitant decrease in Prograf administration.

Drug: basiliximab
Simulect (basiliximab) 20mg intravenously day of transplant and day 4 post operatively. Then Monthly administration of Simulect (basiliximab) 40 mg intravenously for one year duration.
Other Name: Simulect (basiliximab)

Primary Outcome Measures :
  1. To evaluate the risk of sensitization against the chimeric antibody, Simulect. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. To describe the pharmacokinetics of Simulect over the study course. [ Time Frame: one year ]
  2. To determine the absolute and relative number of CD25 receptors on T cells at the end of each dosing interval. [ Time Frame: one year ]
  3. To assess the difference in calculated and measured GFR. [ Time Frame: one year ]
  4. To assess the difference in biopsy proven acute rejection rates and the acute and chronic parameters (chronic allograft injury) on surveillance biopsies. [ Time Frame: one year ]
  5. To assess the difference in vital signs and lab abnormalities [ Time Frame: one year ]
  6. To determine the difference in incidence and severity of albuminuria/proteinuria [ Time Frame: one year ]
  7. To collect safety data on infections and malignancies [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female 18-75
  • First kidney transplant from a living or deceased donor
  • Receiving CNI and MPA
  • Able to tolerate full dose MPA
  • Calculated glomerular filtration rate >=30ml/min by Cockcroft-Gault equation
  • Able to tolerate renal graft biopsies
  • Provided written, informed consent
  • Females of childbearing potential must have a negative pregnancy test within 48 hours prior to the first Simulect administration

Exclusion Criteria:

  • Known hypersensitivity to Simulect
  • Current preformed PRA>10%
  • Multi organ or second kidney transplant
  • Use of any investigational immunosuppressive drug within 1 month of inclusion
  • Female patients who are pregnant, lactating or of child bearing potential and not practicing two approved methods of birth control
  • Known malignancy or history of malignancy other than excised basal or squamous cell carcinoma of the skin
  • HBV, HCV, or HIV positive patients
  • Current severe infection
  • Receiving an organ from an extended criteria donor per United Network for Organ Sharing (UNOS) guidelines
  • Dialysis dependent one month post transplant
  • Live too far away from the transplant center for adequate follow up

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 identifier (NCT number): NCT00928811

United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University College of Medicine
Principal Investigator: Mysore Anil S. Kumar, MD Drexel University College of Medicine

Responsible Party: cynthia gifford, Research Administrator, Drexel University Identifier: NCT00928811     History of Changes
Other Study ID Numbers: 17718
CHI 621A ( Other Identifier: Drexel )
First Posted: June 26, 2009    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

Keywords provided by cynthia gifford, Drexel University:
de novo kidney transplant subjects
calcineurin inhibitors

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs