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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type OTHER

basiliximab

Intervention Type DRUG

Simulect 20 mg intravenously day of transplant and day 4

Simulect

Simulect (basiliximab) intravenously day of transplant and day 4.

Chronic Simulect (basiliximab) administration monthly for one year duration.

Concomitant decrease in Prograf administration.

Group Type EXPERIMENTAL

basiliximab

Intervention Type DRUG

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.

Interventions

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basiliximab

Simulect 20 mg intravenously day of transplant and day 4

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Simulect Simulect (basiliximab)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No