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Renal TransplantPhase 2BELACORNCT02738918

Belatacept (Nulojix) in Renal Transplant Recipient With Mild Immunologic Risk Factor: a Pilot Prospective Study.

A Phase 2 study testing Nulojix (Belatacept) in people with Renal Transplant and Acute Antibody Mediated Rejection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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

BACKGROUND: Antibody-mediated humoral rejection is currently a critical question in renal transplant recipient with immunological risk factors such as pre transplant donor-specific anti HLA antibodies (DSA). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nulojix (Belatacept)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteFrance
Study dates
1 Dec 2014to 18 Sep 2017
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

  • Signed Written Informed Consent
  • Before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read. Then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel.
  • Target Population
  • Renal transplant recipients aged over 18 with DSA at the time of transplant and or on historic serum with mean fluorescence intensity (MFI) between 500 and 3000 (Luminex), available at the time of the transplant.
  • Age and Sex
  • Men and women, ages >18
Show all 13Show fewer
  • Women of childbearing potential (WOCBP) must be using two adequate methods of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug to minimize the risk of pregnancy.
  • WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as:
  • Amenorrhea that has lasted for 12 consecutive months or more without another cause, or
  • For women with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL.
  • Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or who are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential.
  • WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of the investigational product.
  • A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for up to 8 weeks after the last dose of study drug to minimize the risk of pregnancy.

Who cannot join

  • Sex and Reproductive Status
  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug.
  • Women who are pregnant or breastfeeding.
  • Women with a positive pregnancy test.
  • Sexually active fertile men not using effective birth control if their partners are WOCBP.
  • Target Disease Exceptions
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  • Subjects who are EBV-negative or whose EBV status is unknown..
  • Renal Transplantation of Focal and Segmental Glomerulosclerosis
  • Medical history and concomitant diseases
  • Patient with past history of malignancy
  • Physical and Laboratory Test Findings: DSA <500 or>3000
  • Allergies and Adverse Drug Reactions to Nulojix
  • Other Exclusion Criteria
  • Prisoners, or subjects who are involuntarily incarcerated.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Henri Mondor Hospital

    Créteil, 94010

Other trials in France

About this study

Official title: Belatacept (Nulojix) in Renal Transplant Recipient With Mild Immunologic Risk Factor: a Pilot Prospective Study

BACKGROUND: Antibody-mediated humoral rejection is currently a critical question in renal transplant recipient with immunological risk factors such as pre transplant donor-specific anti HLA antibodies (DSA). The immunosuppressive management of the patients is still not well defined and improving both short and long-term graft outcome remains a challenging question. Recent experimental data suggest that Belatacept could induce B cell anergy , induce regulatory B cell and decrease Ig production. These findings are strengthened by the results of both phase II and III clinical studies, showing a significant lower incidence of DSA in patients treated with Belatacept compared to recipients receiving a conventional immunosuppressive regimen with calcineurin inhibitors (CNI).

Primary objective will be the incidence of clinical and subclinical humoral rejection (According to BANFF 2011 Criteria). Secondary objectives will include one-year graft and patient survival, renal function at M12 (MDRD), incidence of cellular rejection (M 12), level of proteinuria (M3 and M12) and DSA outcome (outcome of DSA MFI at JO, M3 and M12). Inclusion period will be of two years. DSA identification and quantitative analysis before and after transplantation will be centralized in only one HLA laboratory Unit (Hospital Saint Louis) for providing results homogeneity.

According to previous clinical studies, the incidence of Acute Antibody Mediated Humoral Rejection is close to 20% in patients with mild immunological risk defined by the presence of DSA at the time of transplant with mean fluorescence intensity (MFI) between 1000 and 3000 (Luminex). In order to demonstrate a significant reduction (40%) of AAMR and sAAMR incidence, 91 patients will be included in this study. Results will be compared to a cohort matched for age, sex, immunological risk factor (DSA), time of transplant, transplant center and grafted with a similar immunosuppressive regimen including CNI instead of Belatacept

Being tested
Nulojix (Belatacept)
Keywords
Renal Transplant, Anti HLA antibodies, Humoral rejection

What participants receive

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

  • Nulojix (Belatacept)Drug

    Nulojix Administration will start the day of transplantation (day 1 and first dosing day);10 mg/kg : (day1, 5,14,28 ), Week 8 and 12 and then 5 mg/kg every 4 weeks until Month 12

Study groups in NCT02738918
Study groupRoleWhat they receive
NulojixExperimentalNot described
Receives: Drug: Nulojix (Belatacept)

What is being measured

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

  1. Incidence of Acute Antibody Mediated Rejection (AAMR) (According to BANFF 2011 Criteria)

    Measured: 12 months (+/- 3 months)

Secondary outcomes (7)

  1. Incidence of subclinical AAMR diagnosed on protocol biopsy

    Measured: 3 months (+/- 1 month), 12 months (+/- 3 month)

  2. Number of patient survival

    Measured: 12 months (+/- 3 months)

  3. Number of graft survival

    Measured: 12 months (+/- 3 months)

  4. Renal function measure by creatinine clearance (ml/min) (MDRD formula)

    Measured: 3 months (+/- 1 month), 12 months (+/- 3 months)

  5. Incidence of clinical and subclinical cellular rejection

    Measured: 12 months (+/- 3 months)

  6. Renal function by level of proteinuria (in g/l)

    Measured: 3 months (+/- 1 month), 12 months (+/- 3 months)

  7. Donor Specific Antibody (DSA) level, evaluate by the measure of maximal Mean Fluorescence Intensity (MFI)by Luminex Single Antigen

    Measured: 3 months (+/- 1 month), 12 months (+/- 3 months)

Timeline

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

  1. First posted14 Apr 2016 (estimated)
  2. Study start1 Dec 2014
  3. Primary completion18 Sep 2017
  4. Study completion18 Sep 2017

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02738918
Sponsor's protocol ID
P121203
Acronym
BELACOR
Status last verified
Nov 2017
First submitted
5 Jan 2016
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D, Klarenbach S, Gill J. Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant. 2011 Oct;11(10):2093-109. doi: 10.1111/j.1600-6143.2011.03686.x. Epub 2011 Aug 30.

    PubMed 21883901

  • Lefaucheur C, Loupy A, Hill GS, Andrade J, Nochy D, Antoine C, Gautreau C, Charron D, Glotz D, Suberbielle-Boissel C. Preexisting donor-specific HLA antibodies predict outcome in kidney transplantation. J Am Soc Nephrol. 2010 Aug;21(8):1398-406. doi: 10.1681/ASN.2009101065. Epub 2010 Jul 15.

    PubMed 20634297

  • Gaston RS, Cecka JM, Kasiske BL, Fieberg AM, Leduc R, Cosio FC, Gourishankar S, Grande J, Halloran P, Hunsicker L, Mannon R, Rush D, Matas AJ. Evidence for antibody-mediated injury as a major determinant of late kidney allograft failure. Transplantation. 2010 Jul 15;90(1):68-74. doi: 10.1097/TP.0b013e3181e065de.

    PubMed 20463643

  • Loupy A, Suberbielle-Boissel C, Hill GS, Lefaucheur C, Anglicheau D, Zuber J, Martinez F, Thervet E, Mejean A, Charron D, Duong van Huyen JP, Bruneval P, Legendre C, Nochy D. Outcome of subclinical antibody-mediated rejection in kidney transplant recipients with preformed donor-specific antibodies. Am J Transplant. 2009 Nov;9(11):2561-70. doi: 10.1111/j.1600-6143.2009.02813.x. Epub 2009 Sep 22.

    PubMed 19775320

  • Haas M, Montgomery RA, Segev DL, Rahman MH, Racusen LC, Bagnasco SM, Simpkins CE, Warren DS, Lepley D, Zachary AA, Kraus ES. Subclinical acute antibody-mediated rejection in positive crossmatch renal allografts. Am J Transplant. 2007 Mar;7(3):576-85. doi: 10.1111/j.1600-6143.2006.01657.x. Epub 2007 Jan 4.

    PubMed 17229067

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nulojix (Belatacept) in people with Renal Transplant and Acute Antibody Mediated Rejection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 13 inclusion and 15 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 5 Jul 2019. 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 France. 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?

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?

Incidence of Acute Antibody Mediated Rejection (AAMR) (According to BANFF 2011 Criteria) (time frame: 12 months (+/- 3 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 NCT02738918, which also lists 5 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 5 Jul 2019.

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