NCT00147381

Brief Summary

The purpose of this study is to determine whether Campath following Tacrolimus monotherapy is more effective in the prevention of renal graft rejection (considering an acute rejection rate of 5% for Campath-1H/Tacrolimus and of 22% for Tacrolimus/MMF/Steroids).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_3

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

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

Enrollment Period

4.6 years

First QC Date

September 6, 2005

Last Update Submit

June 18, 2012

Conditions

Kidney Transplantation

Keywords

Campath-1HAlemtuzumabTacrolimusrenal transplantationimmunosuppressionprevention of acute rejection

Outcome Measures

Primary Outcomes (1)

  • Biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification)

    Month 6

Secondary Outcomes (7)

  • Biopsy proven acute rejection episodes 12 months after transplantation (Banff Classification)

    Year 1

  • Time to 1st biopsy proven acute rejection episode (Banff Cl.)

    Year 1

  • Patient and graft survival

    Year 1

  • Number of patients who will get antilymphocyte preparation for treatment of steroid resistant acute rejection episodes

    Year 1

  • Treatment failure defined as change from immunosuppressive protocol because of biopsy proven intractable rejection

    Year 1

  • +2 more secondary outcomes

Study Arms (3)

Campath-1H 20 mg

EXPERIMENTAL

Day 0: Immediately post transplant surgery patients will receive methylprednisolone 250 mg IV followed one hour later by Campath-1H 20 mg IV infusion over 3-6 hours. Day 1: Same protocol of Campath-1H and methylprednisolone as on Day 0. Day 2: No treatment Day 3: Initial dose of Tacrolimus 0,1 mg/kg/d (0,05 mg/kg/bid) till Month 6: Aim at blood level of 8-12 ng/ml (try to prevent the Tacrolimus trough level falling below 10 ng/ml in the first 3 months). Month 7-12: Maintain the Tacrolimus blood level at 5-8 ng/ml after 6 months.

Drug: Alemtuzumab

Tacrolimus

ACTIVE COMPARATOR

Day 0: Immediately post transplant surgery patients will receive methylprednisolone 250 mg IV followed one hour later by Campath-1H 30 mg IV infusion over 3-6 hours. Day 1: No treatment Day 2: Initial dose Tacrolimus 0.1 mg/kg/d (0.05 mg/kg.bid). till Month 6: Aim at blood level of 8-12 ng/ml (try to prevent the Tacrolimus trough level falling below 10 ng/ml in the first 3 months). Month 7-12: Maintain the Tacrolimus blood level at 5-8 ng/ml after 6 months.

Drug: Tacrolimus

Campath-1H 30 mg

EXPERIMENTAL

Day 0: Immediately post transplant surgery patients will receive methylprednisolone 250 mg IV followed one hour later by Campath-1H 30 mg IV infusion over 3-6 hours. Day 1: No treatment. Day 2: Initial dose Tacrolimus 0.1 mg/kg/d (0.05 mg/kg.bid). till Month 6: Aim at blood level of 8-12 ng/ml (try to prevent the Tacrolimus trough level falling below 10 ng/ml in the first 3 months). Month 7-12: Maintain the Tacrolimus blood level at 5-8 ng/ml after 6 months.

Drug: Alemtuzumab

Interventions

AlemtuzumabDRUG

Day 0: Campath-1H 20 mg IV infusion over 3-6 hours Day 1: Campath-1H 20 mg IV infusion over 3-6 hours

Also known as: MABCAMPATH
Campath-1H 20 mg
TacrolimusDRUG

Day 0: Tacrolimus will be given pre-operatively or immediately post transplant surgery. The recommended initial daily starting dose is 0,1 mg/kg/d orally (0,05 mg/kg/bid) to aim at a whole blood level of 8-12 ng/ml. till Month 6: Aim at blood level of 8-12 ng/ml (try to prevent the Tacrolimus trough level falling below 10 ng/ml in the first 3 months). Month 7-12: Maintain the Tacrolimus blood level at 5-8 ng/ml after 6 months.

Also known as: Prograf, Advagraf
Tacrolimus

Eligibility Criteria

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

You may qualify if:

  • age 18-65
  • endstage renal failure with no previous renal transplantation
  • cadaveric donor
  • written informed consent

You may not qualify if:

  • pregnant or nursing women
  • multi-organ transplant recipients
  • live donor recipients
  • re-transplants
  • panel reactive antibodies (PRA) \> 25%
  • previous treatment with Campath-1H
  • use of other investigational agents within 6 weeks
  • active systemic infection
  • HIV positive patient or donor
  • positive lymphocyte cytotoxicity cross-match between recipient serum and donor cells
  • past history of anaphylaxis following exposure to humanized monoclonal antibodies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (2)

  • Calne R, Moffatt SD, Friend PJ, Jamieson NV, Bradley JA, Hale G, Firth J, Bradley J, Smith KG, Waldmann H. Campath IH allows low-dose cyclosporine monotherapy in 31 cadaveric renal allograft recipients. Transplantation. 1999 Nov 27;68(10):1613-6. doi: 10.1097/00007890-199911270-00032.

    PMID: 10589966BACKGROUND

  • Margreiter R, Klempnauer J, Neuhaus P, Muehlbacher F, Boesmueller C, Calne RY. Alemtuzumab (Campath-1H) and tacrolimus monotherapy after renal transplantation: results of a prospective randomized trial. Am J Transplant. 2008 Jul;8(7):1480-5. doi: 10.1111/j.1600-6143.2008.02273.x.

    PMID: 18510632DERIVED

MeSH Terms

Interventions

AlemtuzumabTacrolimus

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMacrolidesLactonesOrganic Chemicals

Study Officials

  • Raimund Margreiter, Prof. Dr.

    Medical University for Surgery and Transplantation, Innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 7, 2005

Study Start

January 1, 2004

Primary Completion

August 1, 2008

Study Completion

July 1, 2011

Last Updated

June 19, 2012

Record last verified: 2012-06

Locations

AU(1)