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

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

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00928811

Acronym

Simulect

Enrollment

Registered

2009-06-26

Start date

2009-05-31

Completion date

2010-04-30

Last updated

2015-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

Simulect, de novo kidney transplant subjects, calcineurin inhibitors, Prograf

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).

Interventions

DRUGbasiliximab

Simulect 20 mg intravenously day of transplant and day 4

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 describe the pharmacokinetics of Simulect over the study course.	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
To assess the difference in vital signs and lab abnormalities	one year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026