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Kidney TransplantationPhase 2RAPTURENCT00371904

Trial of Rituximab Given Pre-Transplant to Sensitised Live Donor Kidney Recipients

A Phase 2 study testing Rituximab in people with Kidney Transplantation, run by Hunter and New England Health at 3 sites in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

About one third of prospective kidney transplant recipients have antibodies in their blood directed against the tissues of their only available kidney donor. Recently, "desensitisation" treatments when administered pre-transplant have allowed successful transplantation of these patients despite high rates of acute… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplantation
What is being tested?
Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
3 sitesAustralia
Study dates
Apr 2006to Jan 2009
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects, age > 18 years
  • Subjects receiving a single organ renal transplant from a living donor
  • Positive T-cell and/or B-cell crossmatch by complement dependent cytotoxicity (CDC) and/or positive flow cytometry crossmatch with confirmed donor-specific antibodies on solid-phase assay at screening. Positive CDC T-cell and/or B-cell crossmatch titre must be less than or equal to 1:64.
  • Subjects capable of understanding the purposes and risks of the study and who can give written informed consent
  • Exclusion Criteria at Study Entry (4 weeks prior to transplant):
  • Primary renal transplant lost from acute rejection less than six months prior to randomisation
Show all 18Show fewer
  • Women of childbearing potential with a positive serum or urine pregnancy test or nursing mothers
  • Subjects with history of malignancy (other than non melanoma skin cancer that has been totally excised with no recurrence for two years)
  • Subjects with known contraindications to treatment with rituximab
  • Subjects with haemoglobin < 8.5 g/dL, WBC value of < 3000/mm3 or a platelet count of < 50,000/mm3 that is unlikely to resolve prior to randomisation
  • Subjects with a positive ABO crossmatch with donor
  • Subjects with severe diarrhoea or other gastrointestinal disorders that might interfere with the ability to absorb oral medication and is unlikely to resolve prior to randomisation
  • Subjects participating in another interventional clinical trial or requiring treatment with un-marketed investigational drugs or who would be expected to require other medications prohibited by the protocol
  • Subjects who cannot be followed for the study duration
  • Subjects with disorders or conditions that may interfere with the ability to comply with study procedures and/or requirements
  • Additional Exclusion Criteria at Day -2 before Transplantation:
  • All exclusion criteria as at study entry
  • Positive T- and/or B-cell CDC crossmatch at Day -2

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

Paul R Trevillian, MBBS, FRACP contact

+61414417311

Paul.Trevillian@hnehealth.nsw.gov.au

Solomon Cohney, MBBS, FRACP, PhD contact

+61393427159

Solomon.Cohney@wh.org.au

Australia3 sites, 3 recruiting

  • Monash Medical Centre

    Clayton, Victoria, 3168

    John Kanellis, MBBS, PhD, FRACP, +61395943070, john.kanellis@med.monash.edu.au

    Janet Andrew, +61395943526, j.andrew@southernhealth.org.au

    Not yet recruiting

  • Newcastle Transplant Unit, John Hunter Hospital

    Newcastle, New South Wales, 2305

    Paul R Trevillian, MBBS, FRACP, +61249214326, Paul.Trevillian@hnehealth.nsw.gov.au

    Ann Stein, RN, +61249214341, Ann.Stein@hnehealth.nsw.gov.au

    Recruiting

  • Royal Melbourne Hospital

    Parkville, Victoria, 3052

    Shlomo Cohney, MBBS, +61393427159, Solomon.Cohney@wh.org.au

    Maria Farrell, +61393427077, maria.farrell@mh.org.au

    Not yet recruiting

Other trials in Australia

About this study

Official title: A Prospective Open Label Randomised Multicentre Study Evaluating the Efficacy & Safety of Rituximab Given Pre-Transplant to Sensitised Renal Allograft Recipients in Addition to a "Standard" Desensitisation Regimen Consisting of PE/IVIG & MMF

About one third of prospective kidney transplant recipients have antibodies in their blood directed against the tissues of their only available kidney donor. Recently, "desensitisation" treatments when administered pre-transplant have allowed successful transplantation of these patients despite high rates of acute antibody mediated rejection (AAMR). The investigators propose to test in a randomised controlled trial whether rituximab, a monoclonal antibody that depletes B-lymphocytes, will safely lower antibody mediated rejection (AMR) rates when added to "standard" therapy. The investigators will also test whether rituximab enables more patients to achieve a negative crossmatch against their donor and thereby allow more transplants to proceed.

Read the detailed description

This study is designed to investigate in a prospective, randomised fashion whether a single intravenous dose of rituximab (375 mg/m2) given two weeks prior to transplant, in addition to standard therapy, will allow sensitised renal transplant subjects to achieve a negative CDC crossmatch and thereby proceed to live donor transplantation. We will also evaluate whether rituximab will reduce the number of AAMR episodes in the post-transplant period, compared to controls. All eligible subjects must have a positive T- and/or B-cell CDC or flow cytometry crossmatch and have donor-specific antibodies identified by solid-phase assay at screening. All subjects will receive a standard desensitisation regimen that includes plasma exchange/IVIG + MMF before and immediately after transplantation followed by a standard care immunosuppressive regimen (IL-2R antagonist, tacrolimus, mycophenolate mofetil [MMF] and corticosteroids) after transplantation.

Being tested
Rituximab, Standard Care
Keywords
Rituximab, donor, sensitised, antibody, rejection
Medical subject headings
Rejection, Psychology

What participants receive

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

  • RituximabDrug

    Also called Mabthera

    Single dose (375 mg/m2) of rituximab to be given intravenously (IV) 14 days prior to transplantation

  • Standard CareDrug

    Standard care

Study groups in NCT00371904
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Rituximab
2Active comparatorNot described
Receives: Drug: Standard Care

What is being measured

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

  1. Biopsy proven antibody mediated rejection

    Measured: 12 months

Secondary outcomes (12)

  1. Elimination of donor specific antibodies (DSA)

    Measured: Day - 2 , 7; Months 1, 3, 6, 9 and 12

  2. C4d in biopsies

    Measured: Day 7; Months 3 and 12

  3. Plasma exchanges

    Measured: Month 12

  4. Death

    Measured: Month 12

  5. Treated rejection

    Measured: Month 12

  6. Graft loss

    Measured: Months 3, 6 and 12

  7. Treatment failure

    Measured: Months 6 and 12

  8. Calculation of glomerular filtration rate (GFR)

    Measured: Months 1 - 12

  9. Slope of 1/serum creatinine (Ser. Cr)

    Measured: Months 6 and 12

  10. 24-hour U protein

    Measured: Months 3 and 12

  11. Safety

    Measured: Month 12

  12. Cancer and infections

    Measured: Month 12

Timeline

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

  1. First posted4 Sep 2006 (estimated)
  2. Study startApr 2006
  3. Study completionJan 2009 (estimated)

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
192 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00371904
Sponsor's protocol ID
RAPTURE
Acronym
RAPTURE
Status last verified
May 2008
First submitted
1 Sep 2006
Last updated
21 May 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab in people with Kidney Transplantation, run by Hunter and New England Health at 3 sites in Australia.

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 18 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 21 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Paul R Trevillian, MBBS, FRACP (+61414417311, Paul.Trevillian@hnehealth.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biopsy proven antibody mediated rejection (time frame: 12 months). 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 NCT00371904.

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 21 May 2008.

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