Clinical trial NCT00928811: Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: End Stage Renal Disease
Keywords: Simulect
de novo kidney transplant subjects
calcineurin inhibitors
Prograf
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2009-06-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: To evaluate the risk of sensitization against the chimeric antibody, Simulect.
timeFrame: one year
Secondary outcomes:
measure: To describe the pharmacokinetics of Simulect over the study course.
timeFrame: one year
measure: To determine the absolute and relative number of CD25 receptors on T cells at the end of each dosing interval.
timeFrame: one year
measure: To assess the difference in calculated and measured GFR.
timeFrame: one year
measure: To assess the difference in biopsy proven acute rejection rates and the acute and chronic parameters (chronic allograft injury) on surveillance biopsies.
timeFrame: one year
measure: To assess the difference in vital signs and lab abnormalities
timeFrame: one year
measure: To determine the difference in incidence and severity of albuminuria/proteinuria
timeFrame: one year
measure: To collect safety data on infections and malignancies
timeFrame: one year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
Study officials:
affiliation: Drexel University College of Medicine
name: Mysore Anil S. Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: