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

Phase 2

Terminated

• Conditions: End Stage Renal Disease
• Interventions: Drug: basiliximab

• Registration Number: NCT00928811
• Lead Sponsor: Drexel University College of Medicine

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).

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simulect	basiliximab	Simulect (basiliximab) intravenously day of transplant and day 4. Chronic Simulect (basiliximab) administration monthly for one year duration. Concomitant decrease in Prograf administration.
Control	basiliximab	Standard of care administration with Simulect (basiliximab)being administered as per induction therapy on day of transplant and day 4.

Primary Outcome Measures

Name	Time	Method
To evaluate the risk of sensitization against the chimeric antibody, Simulect.	one year

Secondary Outcome Measures

Name	Time	Method
To describe the pharmacokinetics of Simulect over the study course.	one year
To assess the difference in calculated and measured GFR.	one year
To determine the absolute and relative number of CD25 receptors on T cells at the end of each dosing interval.	one year
To determine the difference in incidence and severity of albuminuria/proteinuria	one year
To collect safety data on infections and malignancies	one year
To assess the difference in vital signs and lab abnormalities	one year
To assess the difference in biopsy proven acute rejection rates and the acute and chronic parameters (chronic allograft injury) on surveillance biopsies.	one year

Trial Locations

Locations (1)

Drexel University College of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States