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Acute RejectionPhase 3RIACTNCT01117662

Efficacy of Rituximab in Acute Cellular Rejection in Renal Transplant Patients

A Phase 3 study testing Rituximab in people with Acute Rejection, run by Hannover Medical School at 14 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Acute kidney allograft rejection is the major cause for a loss of graft function and has a negative impact on long-term graft survival. Anti-rejection therapy traditionally focuses on T cell-mediated mechanisms of renal allograft rejection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Rejection
What is being tested?
Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
13 participants
Where
14 sitesGermany
Study dates
May 2012to 23 Aug 2016
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • male or female patients age ≥ 18 at the time of the inclusion in the study
  • male or female patients after kidney transplantation if medically justifiable (cave: previous immunosuppression, particularly prior induction therapies or biologicals).
  • Proof of an acute rejection in kidney transplant according to Banff-criteria: T-cell-mediated rejection as borderline, grade IA/B, IIA/B (no v-only), if one or more results are available as significant B-cell infiltrates CD20≥20 / high power field, glomerulitis, peritubular capillaritis or C4d positivity (with the exception of ABO-incompatible transplantations) as well as patients who have no T-cell-mediated acute rejection, but signs of acute humoral rejection (as listed above according to the criteria glomerulitis, peritubular capillaritis, C4d positivity) who have to be treated according to medical opinion of the physician with steroid therapy. The evidence of rejection can be performed by a protocol or indication biopsy.
  • SV40-negativity in the biopsy
  • GFR calculated using the MDRD-Formula > 25 ml/min/1,73 m² in the time period before the noticed rejection.
  • Presence of a negative pregnancy test and consent to a highly effective contraceptive method (i.e. failure rate less than 1% per year, which are implants, injectable contraceptives, combined oral contraceptives, intrauterine devices (only hormone spirals), sexual abstinence or vasectomy of the partner) in patients of child-bearing age. This is not required when bilateral sterilization or ovariectomy of the patient and in patients that have exclusively female sex partners. Presence of consent to a highly effective contraceptive method for male patient.
  • Informed consent

Who cannot join

  • Known contraindications, resp. incompatibility for Rituximab and/or for the concomitant medication
  • Administration of Rituximab within the last 12 months before inclusion
  • Simultaneous participation in an other clinical study or participation in an other clinical study within the last 30 days
  • Breastfeeding women or pregnant women
  • Persons who fail to assess essence, meaning and significance of the clinical study and act along these lines (according to § 40 Abs. 4 and § 41 Abs. 2 and Abs. 3 AMG)
  • Existence of an active CMV-infection, existence of a HIV-infection, existence of a replicative hepatitis B or C, existence of other grave infections
Show all 13Show fewer
  • Cardiac insufficiency in phase NYHA III-IV
  • High grade cardiac arrhythmias
  • Unstable coronary heart disease
  • Poorly adjusted diabetes mellitus (HbA1c > 10 %) at the time of the inclusion in the study.
  • State after splenectomy
  • Contra-indication referring to a renewed transplant biopsy (e.g. coagulopathy, anticoagulation)
  • Other exclusion criteria according to the estimate of the attending doctor (e.g. aggravation of the general health condition, occurrence of a malignant disease)

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Germany14 sites

  • Universitätsklinikum der RWTH Aachen Medizinische Klinik II

    Aachen, 52074

  • Charité Campus Mitte Universitätsmedizin Berlin

    Berlin, 10117

  • Universitätsklinikum Köln Medizinische Klinik IV Nephrologie

    Cologne, 50937

  • Kliniken der Stadt Köln gGmbH Medizinische Klinik I

    Cologne, 51109

  • Universitätsklinikum Düsseldorf Klinik für Nephrologie

    Düsseldorf, 40225

  • Universitätsklinikum Erlangen Nephrologie und Hypertensiologie

    Erlangen, 91054

  • Universitätsklinikum Essen Klinik für Nephrologie

    Essen, 45147

  • Universitätsklinikum Freiburg Medzinische Klinik IV Nephrologie Freiburg

    Freiburg im Breisgau, 79106

  • Nephrologisches Zentrum Niedersachsen 34346 Hannoversch Münden

    Hannoversch Münden, 34346

  • Hannover Medical School

    Hanover, Lower Saxony, 30625

  • Universitätsklinikum Jena Klinik für Innere Medizin III

    Jena, 07747

  • Universitätsklinikum Schleswig-Holstein Campus Kiel Klinik für Nieren- und Hochdruckkrankheiten Kiel

    Kiel, 24105

  • Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Uniklinik München Klinikum Großhadern

    München, 81377

  • Universitätsklinikum Münster Innere Medizin / Nephrologie

    Münster, 48149

Other trials in Germany

About this study

Official title: Efficacy of Rituximab in Acute Cellular Rejection With B-cell Infiltrates in Renal Transplant Patients - Randomized Placebo Controlled Double Blind Trial

Acute kidney allograft rejection is the major cause for a loss of graft function and has a negative impact on long-term graft survival. Anti-rejection therapy traditionally focuses on T cell-mediated mechanisms of renal allograft rejection. However, available agents that affect T-cell pathways have only little impact on long-term graft survival. There is increasing evidence that B-cells play an important role in acute transplant rejections. CD20+ B cell infiltrates in acute T-cell mediated rejections are frequent and correlate with a worse response to conventional anti-rejection treatment and an increased risk of graft loss. In one pilot study, supported by several case reports, a beneficial effect of Rituximab for the treatment of acute rejection episodes with intrarenal B-cell infiltrates was shown. However, despite the promise of these observations solid evidence is required before incorporating this treatment option into a general treatment recommendation.

In a multicenter randomized placebo controlled double blind phase III trial the investigators want to demonstrate that Rituximab in addition to standard treatment with steroid-boli is superior to the standard treatment alone regarding long-term kidney function. If the proposed study proves that Rituximab treatment of acute rejections is beneficial for the long-term allograft function, the conventional rejection therapy needs to be revised to this novel concept of B- cell targeting

Conditions
Acute Rejection
Being tested
Rituximab, Placebo
Keywords
transplantation, acute rejection, kidney

What participants receive

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

  • RituximabDrug

    Also called MabThera

    Intravenous application of Rituximab 375mg/m² body surface in 250 ml NaCl 0,9 % over 4 hours

  • PlaceboDrug

    Intravenous application of placebo (NaCl 0,9 %) matching active treatment

Study groups in NCT01117662
Study groupRoleWhat they receive
RituximabExperimentalIntravenous application of Rituximab 375mg/m² body surface in 250 ml NaCl 0,9 % over 4 hours
Receives: Drug: Rituximab
ControlPlacebo comparatorIntravenous application of placebo (NaCl 0,9 %) matching active treatment
Receives: Drug: Placebo

What is being measured

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

  1. Change of the GFR (glomerular filtration rate) one year after intervention compared to the baseline GFR before the rejection, which is calculated by a defined algorithm

    Measured: Baseline, 1 year

Secondary outcomes (1)

  1. Progression of interstitial fibrosis and tubular atrophy between the biopsy that led to enrolment in the study and a scheduled protocol biopsy one year after intervention ("∆IFTA-Score")

    Measured: 1 year

Timeline

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

  1. First posted5 May 2010 (estimated)
  2. Study startMay 2012
  3. Primary completionMay 2016
  4. Study completion23 Aug 2016

Why it stopped: The planned recruitment number of 180 Patient could not been achieved.

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01117662
Sponsor's protocol ID
200710602
Acronym
RIACT
Status last verified
Aug 2018
First submitted
28 Apr 2010
Last updated
22 Aug 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Schiffer L, Schiffer M, Merkel S, Schwarz A, Mengel M, Jurgens C, Schroeder C, Zoerner AA, Pullmann K, Brocker V, Becker JU, Dammrich ME, Trader J, Grosshennig A, Biertz F, Haller H, Koch A, Gwinner W. Rationale and design of the RIACT-study: a multi-center placebo controlled double blind study to test the efficacy of RItuximab in Acute Cellular tubulointerstitial rejection with B-cell infiltrates in renal Transplant patients: study protocol for a randomized controlled trial. Trials. 2012 Oct 26;13:199. doi: 10.1186/1745-6215-13-199.

    PubMed 23101480

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab in people with Acute Rejection, run by Hannover Medical School at 14 sites in Germany.

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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: The planned recruitment number of 180 Patient could not been achieved.). Results are not available in the source record.

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?

Change of the GFR (glomerular filtration rate) one year after intervention compared to the baseline GFR before the rejection, which is calculated by a defined algorithm (time frame: Baseline, 1 year). 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 NCT01117662, which also lists 1 linked publication.

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 22 Aug 2018.

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