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

Drexel University

Status and phase: Terminated; Phase 3; Phase 2

Conditions: End Stage Renal Disease

Treatments: Drug: basiliximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00928811

CHI 621A (Other Identifier)

17718

Details and patient eligibility

About

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.

Full 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).

Enrollment: 5 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Control

Other group

Description:

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

Treatment:

Drug: basiliximab

Drug: basiliximab

Simulect

Experimental group

Description:

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

Treatment:

Drug: basiliximab

Drug: basiliximab