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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Drexel University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novartis
Information provided by:
Drexel University
ClinicalTrials.gov Identifier:
NCT00928811
First received: June 25, 2009
Last updated: May 24, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention Phase
Reduction in Sequelae Related to Calcineurin Inhibitors
Chimeric Antibody Sensitization
Allograft Rejection
 Drug: basiliximab
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Basiliximab
U.S. FDA Resources

Further study details as provided by Drexel University:

Primary Outcome Measures:
  • To evaluate the risk of sensitization against the chimeric antibody, Simulect. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To describe the pharmacokinetics of Simulect over the study course. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • To determine the absolute and relative number of CD25 receptors on T cells at the end of each dosing interval. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • To assess the difference in calculated and measured GFR. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To assess the difference in vital signs and lab abnormalities [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • To determine the difference in incidence and severity of albuminuria/proteinuria [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • To collect safety data on infections and malignancies [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: May 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Standard of care administration with Simulect 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 intravenously day of transplant and day 4. Then chronic Simulect administration monthly for one year duration. Concomitant decrease in Prograf administration.
 Drug: basiliximab
Simulect 20mg intravenously day of transplant and day 4 post operatively. Then chronic administration of Simulect 40 mg intravenously for one year duration.
Other Name: Simulect

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928811

Contacts
Contact: Patricia M. Gribbon, MSN, RNC 215/762.4429 pgribbon@drexedmed.edu
Contact: Cynthia Gifford-Hollingsworth, MSN, CPNP 215/762.8189 cgiffor1@drexelmed.edu

Locations
United States, Pennsylvania
Drexel University College of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Patricia M. Gribbon, MSN, RNC     215-762-4429     pgribbon@drexelmed.edu    
Contact: Cynthia Gifford-Hollingsworth, MSN, CPNP     215/762.8189     cgiffor1@drexelmed.edu    
Principal Investigator: Mysore Anil S. Kumar, MD            
Sponsors and Collaborators
Drexel University College of Medicine
Novartis
Investigators
Principal Investigator: Mysore Anil S. Kumar, MD Drexel University College of Medicine
  More Information

No publications provided

Responsible Party: Mysore Anil S. Kumar, MD /Professor of Surgery, Drexel University College of Medicine
ClinicalTrials.gov Identifier: NCT00928811     History of Changes
Other Study ID Numbers: 17718, CHI 621A
Study First Received: June 25, 2009
Last Updated: May 24, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Drexel University:
Simulect
de novo kidney transplant subjects
calcineurin inhibitors
Prograf

Additional relevant MeSH terms:
Basiliximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013