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Kidney TransplantationPhase 3NCT00147381

Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection

A Phase 3 study testing Alemtuzumab and Tacrolimus in people with Kidney Transplantation, run by Dr. Claudia Bösmüller at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Kidney Transplantation
What is being tested?
Alemtuzumab and Tacrolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
1 siteAustria
Study dates
Jan 2004to Jul 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • pregnant or nursing women
  • multi-organ transplant recipients
  • live donor recipients
  • re-transplants
  • panel reactive antibodies (PRA) > 25%
  • previous treatment with Campath-1H
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • University Hospital Innsbruck

    Innsbruck, Tyrol, 6020

Other trials in Austria

About this study

Official title: Effectiveness and Safety of Campath-1H as an Induction Agent in Combination With Tacrolimus Monotherapy for Prevention of Graft Rejection Compared to Tacrolimus in Combination With MMF and Steroids in Cadaveric Kidney Transplantation

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).

Read the detailed description

Major advances in immunosuppressive therapy have resulted in long-term graft survival by the use of various drug combinations.However, these combinations carry the risk of e.g. infection, malignancy, renal damage, hypertension, diabetes, hyperlipidemia, hirsutism, cushingoid facial appearance and bone necrosis.Therefore one of the major goals should be to reduce immunosuppression without increasing risk of rejections.

Based on good results of a pilot study (not a single acute rejection episode during the 18-20 months observation period despite low level of Tacrolimus and absence of steroids) this randomised trial was designed to further evaluate the safety and efficacy of Campath-1H.

Being tested
Alemtuzumab, Tacrolimus
Keywords
Campath-1H, Alemtuzumab, Tacrolimus, renal transplantation, immunosuppression, prevention of acute rejection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlemtuzumabDrug

    Also called MABCAMPATH

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

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

  • TacrolimusDrug

    Also called Prograf, Advagraf

    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.

  • AlemtuzumabDrug

    Also called MABCAMPATH

    Day 0: Campath-1H 30 mg IV infusion over 3-6 hours

    Day 1: Campath-1H 30 mg IV infusion over 3-6 hours

Study groups in NCT00147381
Study groupRoleWhat they receive
Campath-1H 20 mgExperimentalDay 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.
Receives: Drug: Alemtuzumab
TacrolimusActive comparatorDay 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.
Receives: Drug: Tacrolimus
Campath-1H 30 mgExperimentalDay 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.
Receives: Drug: Alemtuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Month 6

Secondary outcomes (7)

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

    Measured: Year 1

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

    Measured: Year 1

  3. Patient and graft survival

    Measured: Year 1

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

    Measured: Year 1

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

    Measured: Year 1

  6. Adverse events (e.g. infections, PTLD)

    Measured: Year 1

  7. Creatinine clearance

    Measured: Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2005 (estimated)
  2. Study startJan 2004
  3. Primary completionAug 2008
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00147381
Sponsor's protocol ID
TaCam 07_MC
Other IDs
DE-02-RG-121/Margreiter
Status last verified
Jun 2012
First submitted
6 Sep 2005
Last updated
19 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 10589966

  • 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.

    PubMed 18510632

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alemtuzumab and Tacrolimus in people with Kidney Transplantation, run by Dr. Claudia Bösmüller at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification) (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00147381, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2012.

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