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

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 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.

Study Overview

• Status: Terminated
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Drug: basiliximab; Drug: basiliximab

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
• Enrollment (Actual): 5
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; 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 Names: Simulect; 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 Names: Simulect (basiliximab)
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 20 mg intravenously day of transplant and day 4; Other Names: Simulect; 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 Names: Simulect (basiliximab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the risk of sensitization against the chimeric antibody, Simulect.	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
To describe the pharmacokinetics of Simulect over the study course.	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 assess the difference in calculated and measured GFR.	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
To assess the difference in vital signs and lab abnormalities	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

Collaborators and Investigators

• Sponsor: Drexel University College of Medicine
• Collaborators: Novartis
• Investigators: Principal Investigator: Mysore Anil S. Kumar, MD, Drexel University College of Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: June 25, 2009
• First Submitted That Met QC Criteria: June 25, 2009
• First Posted (Estimate): June 26, 2009

Study Record Updates

• Last Update Posted (Estimate): February 10, 2015
• Last Update Submitted That Met QC Criteria: February 9, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Prograf; Simulect; calcineurin inhibitors; de novo kidney transplant subjects
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Basiliximab
• Other Study ID Numbers: 17718 (UK Clinical Research Network); CHI 621A (Other Identifier: Drexel)