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

Primary Purpose

End Stage Renal Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
basiliximab
basiliximab
Sponsored by
Drexel University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Simulect, de novo kidney transplant subjects, calcineurin inhibitors, Prograf

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Drexel University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Simulect

Arm Description

Standard of care administration with Simulect (basiliximab)being administered as per induction therapy on day of transplant and day 4.

Simulect (basiliximab) intravenously day of transplant and day 4. Chronic Simulect (basiliximab) administration monthly for one year duration. Concomitant decrease in Prograf administration.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 25, 2009
Last Updated
February 9, 2015
Sponsor
Drexel University College of Medicine
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00928811
Brief Title
Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant
Acronym
Simulect
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

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Investigator left University 04/2010
Study Start Date
May 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Drexel University College of Medicine
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Simulect, de novo kidney transplant subjects, calcineurin inhibitors, Prograf

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Standard of care administration with Simulect (basiliximab)being administered as per induction therapy on day of transplant and day 4.
Arm Title
Simulect
Arm Type
Experimental
Arm Description
Simulect (basiliximab) intravenously day of transplant and day 4. Chronic Simulect (basiliximab) administration monthly for one year duration. Concomitant decrease in Prograf administration.
Intervention Type
Drug
Intervention Name(s)
basiliximab
Other Intervention Name(s)
Simulect
Intervention Description
Simulect 20 mg intravenously day of transplant and day 4
Intervention Type
Drug
Intervention Name(s)
basiliximab
Other Intervention Name(s)
Simulect (basiliximab)
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the risk of sensitization against the chimeric antibody, Simulect.
Time Frame
one year
Secondary Outcome Measure Information:
Title
To describe the pharmacokinetics of Simulect over the study course.
Time Frame
one year
Title
To determine the absolute and relative number of CD25 receptors on T cells at the end of each dosing interval.
Time Frame
one year
Title
To assess the difference in calculated and measured GFR.
Time Frame
one year
Title
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
Title
To assess the difference in vital signs and lab abnormalities
Time Frame
one year
Title
To determine the difference in incidence and severity of albuminuria/proteinuria
Time Frame
one year
Title
To collect safety data on infections and malignancies
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mysore Anil S. Kumar, MD
Organizational Affiliation
Drexel University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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