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

End Stage Renal Disease Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00928811
• Other study ID #: 17718
• Secondary ID: CHI 621A
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: June 25, 2009
• Last updated: February 9, 2015
• Start date: May 2009
• Est. completion date: April 2010

Study information

• Verified date: February 2015
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• basiliximab
Simulect 20 mg intravenously day of transplant and day 4
• 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.

Locations

Country	Name	City	State
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University College of Medicine	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the risk of sensitization against the chimeric antibody, Simulect.		one year
Secondary	To describe the pharmacokinetics of Simulect over the study course.		one year
Secondary	To determine the absolute and relative number of CD25 receptors on T cells at the end of each dosing interval.		one year
Secondary	To assess the difference in calculated and measured GFR.		one year
Secondary	To assess the difference in biopsy proven acute rejection rates and the acute and chronic parameters (chronic allograft injury) on surveillance biopsies.		one year
Secondary	To assess the difference in vital signs and lab abnormalities		one year
Secondary	To determine the difference in incidence and severity of albuminuria/proteinuria		one year
Secondary	To collect safety data on infections and malignancies		one year