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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


Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Reduction in Sequelae Related to Calcineurin Inhibitors, Chimeric Antibody Sensitization, Allograft Rejection

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Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the risk of sensitization against the chimeric antibody, Simulect.

Outcome Time Frame:

one year

Safety Issue:

Yes

Principal Investigator

Mysore Anil S. Kumar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Drexel University College of Medicine

Authority:

United States: Institutional Review Board

Study ID:

17718

NCT ID:

NCT00928811

Start Date:

May 2009

Completion Date:

May 2011

Related Keywords:

  • Reduction in Sequelae Related to Calcineurin Inhibitors
  • Chimeric Antibody Sensitization
  • Allograft Rejection
  • Simulect
  • de novo kidney transplant subjects
  • calcineurin inhibitors
  • Prograf

Name

Location

Drexel University College of MedicinePhiladelphia, Pennsylvania  19129