- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00928811
Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant (Simulect)
February 9, 2015 updated by: cynthia gifford, Drexel University College of Medicine
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19102
- Drexel University College of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
Simulect 20 mg intravenously day of transplant and day 4
Other Names:
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:
|
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. |
Simulect 20 mg intravenously day of transplant and day 4
Other Names:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the risk of sensitization against the chimeric antibody, Simulect.
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To describe the pharmacokinetics of Simulect over the study course.
Time Frame: one year
|
one year
|
To determine the absolute and relative number of CD25 receptors on T cells at the end of each dosing interval.
Time Frame: one year
|
one year
|
To assess the difference in calculated and measured GFR.
Time Frame: one year
|
one year
|
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
|
one year
|
To assess the difference in vital signs and lab abnormalities
Time Frame: one year
|
one year
|
To determine the difference in incidence and severity of albuminuria/proteinuria
Time Frame: one year
|
one year
|
To collect safety data on infections and malignancies
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mysore Anil S. Kumar, MD, Drexel University College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17718 (UK Clinical Research Network)
- CHI 621A (Other Identifier: Drexel)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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