NCT00928811

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

11 months

First QC Date

June 25, 2009

Last Update Submit

February 9, 2015

Conditions

End Stage Renal Disease

Keywords

Simulectde novo kidney transplant subjectscalcineurin inhibitorsPrograf

Outcome Measures

Primary Outcomes (1)

  • To evaluate the risk of sensitization against the chimeric antibody, Simulect.

    one year

Secondary Outcomes (7)

  • To describe the pharmacokinetics of Simulect over the study course.

    one year

  • 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 assess the difference in vital signs and lab abnormalities

    one year

  • +2 more secondary outcomes

Study Arms (2)

Control

OTHER

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

Drug: basiliximab

Simulect

EXPERIMENTAL

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

Drug: basiliximab

Interventions

basiliximabDRUG

Simulect 20 mg intravenously day of transplant and day 4

Also known as: Simulect
Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Known hypersensitivity to Simulect
  • Current preformed PRA\>10%
  • Multi organ or second kidney transplant
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Basiliximab

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Mysore Anil S. Kumar, MD

    Drexel University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Administrator

Study Record Dates

First Submitted

June 25, 2009

First Posted

June 26, 2009

Study Start

May 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

February 10, 2015

Record last verified: 2015-02

Locations

US(1)