NCT00365846

Brief Summary

The purpose of the study is to see if campath-1H can be used in first time renal transplant subjects to prevent rejection and reduce the overall amount of anti-rejection medications that patients take on a daily basis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2000

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2006

Completed
6 years until next milestone

Results Posted

Study results publicly available

July 30, 2012

Completed
Last Updated

October 3, 2012

Status Verified

September 1, 2012

Enrollment Period

4.9 years

First QC Date

August 16, 2006

Results QC Date

June 22, 2012

Last Update Submit

September 21, 2012

Conditions

Renal Transplant

Keywords

prevent kidney rejection

Outcome Measures

Primary Outcomes (1)

  • Incidence of Allograft Rejection

    3 years

Secondary Outcomes (5)

  • Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment)

    3 years

  • Patient Survival

    3 years

  • Incidence of Post-transplant Infection

    3 years

  • Incidence of Malignancies

    3 years

  • Kidney Allograft Survival

    3 years

Study Arms (1)

Campath 1H induction w/ Sirolimus immunosuppression

EXPERIMENTAL

Campath 1H at day -1 and 0 of kidney transplant followed by long term CNI free immunosuppressive therapy with Sirolimus,

Drug: Campath-1H

Interventions

Campath-1HDRUG
Campath 1H induction w/ Sirolimus immunosuppression

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • primary renal transplant (not HLA identical)
  • ages 18-60 years

You may not qualify if:

  • recipient panel reactive antibody level \>10%
  • recipient of a DCD kidney
  • no prior organ transplant
  • no multi-organ transplant recipient
  • no subject who is currently receiving systemic corticosteroids
  • no pregnant or lactating subjects
  • no history of Hepatitis B, C or HIV positivity
  • no recipient of a kidney with cold ischemia time \>36 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

  • Barth RN, Janus CA, Lillesand CA, Radke NA, Pirsch JD, Becker BN, Fernandez LA, Thomas Chin L, Becker YT, Odorico JS, D'Alessandro AM, Sollinger HW, Knechtle SJ. Outcomes at 3 years of a prospective pilot study of Campath-1H and sirolimus immunosuppression for renal transplantation. Transpl Int. 2006 Nov;19(11):885-92. doi: 10.1111/j.1432-2277.2006.00388.x.

    PMID: 17018123RESULT

  • Fehr T, Hubel K, de Rougemont O, Abela I, Gaspert A, Gungor T, Hauri M, Helmchen B, Linsenmeier C, Muller T, Nilsson J, Riesterer O, Scandling JD, Schanz U, Cippa PE. Successful Induction of Specific Immunological Tolerance by Combined Kidney and Hematopoietic Stem Cell Transplantation in HLA-Identical Siblings. Front Immunol. 2022 Jan 31;13:796456. doi: 10.3389/fimmu.2022.796456. eCollection 2022.

    PMID: 35173720DERIVED

MeSH Terms

Interventions

Alemtuzumab

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Stuart Knechtle, MD
Organization
Emory University
stuart.knechtle@emoryhealthcare.org
404-727-8465

Study Officials

  • Stuart J Knechtle

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 18, 2006

Study Start

August 1, 2000

Primary Completion

July 1, 2005

Study Completion

July 1, 2006

Last Updated

October 3, 2012

Results First Posted

July 30, 2012

Record last verified: 2012-09

Locations

US(1)