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Renal Transplant RejectionPhase 1/2NCT02500251

Belimumab Impacting Transplant Eligibility

A Phase 1/2 study testing belimumab, Bortezomib and Rituximab in people with Renal Transplant Rejection, run by E. Steve Woodle at 2 sites in United States.

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

This study is a prospective, open label, phase I/II pilot study. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Renal Transplant Rejection
What is being tested?
belimumab, Bortezomib and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
2 sitesUnited States
Study dates
Jun 2015to Aug 2018
Phase
Phase 1/2
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is between 18 and 65 years of age, inclusive, with end-stage renal disease awaiting kidney transplantation.
  • Patient with eligible living donor will have: DSA against living donor of > 5,000 MFI or a positive T or B cell flow cytometry crossmatch.
  • Patient that is on the kidney transplant waiting list awaiting a deceased donor transplant and has an iAb of > 8,000 MFI or has a current or peak calculated panel reactive antibody (cPRA) >20%.
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Female subject is either post-menopausal for one year prior to screening or surgically sterilized. Women of childbearing potential (WOCBP) must not become pregnant and so must be sexually inactive by abstinence (starting 2 weeks prior to the 1st belimumab and/or bortezomib dose) or use contraceptive methods with a failure rate of < 1% (starting 1 month prior to the 1st belimumab and/or bortezomib dose) for the duration of the study through 16 weeks after the last belimumab and/or bortezomib dose. WOCBP must have a negative urine or serum pregnancy test at screening and < 7 days prior to the first belimumab and/or bortezomib dose.
  • Male subjects, even if surgically sterilized (i.e., status post vasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 16 weeks after the last dose of belimumab and/or bortezomib, or completely abstain from heterosexual intercourse.
  • Review of pre-transplant medical clearance by the patient's transplant nephrologist to assure the patient is medically acceptable for study entry.
  • Cardiac evaluation by transplant nephrologist with clearance documented in writing to participate in the study.

Who cannot join

  • Know hypersensitivity to bortezomib, boron or mannitol, rituximab, belimumab or any of its components.
  • Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
  • Subjects judged by the investigator to be at significant risk of failing to comply with the requirements of the protocol or unable to cooperate or communicate with the investigator.
  • Abnormal ECG with clinically significant ventricular arrhythmias or other conduction abnormality that in the opinion of the investigator warrants exclusion of the subject from the trial.
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (Appendix A), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any abnormality on ECG performed within 30 days of consent has to be documented by the investigator or the patient's transplant nephrologist as not medically relevant.
  • Patient has Grade 2 peripheral neuropathy by CTCAE criteria within 14 days before enrollment.
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  • Patients with an absolute neutrophil count < 1,000/mm3 or platelet count < 75,000/mm3 within 30 days of consent.
  • Patient has received intravenous cyclophosphamide within 180 days prior to belimumab, any biologic investigational agent within 365 days prior to belimumab, or any non-biologic investigational agent within 30 days (or 5 half-lives, whichever is greater) prior to belimumab.
  • Receipt of a live vaccine within 30 days prior to initiation of study treatment.
  • Received blood transfusions within 30 days prior to trial entry.
  • Have any intercurrent significant medical (other than renal disease) or psychiatric illness that the investigator considers would make the candidate unsuitable for the study.
  • Have a historically positive HIV test or test positive for HIV within one year of consent.
  • Hepatitis status:
  • Hepatitis B: Serologic evidence of current or past Hepatitis B (HB) infection based on the results of testing for HBsAg and anti-HBc as follows: i. Patients positive for HBsAg or HBcAb historically or on testing performed within one year of consent are excluded b. Hepatitis C: Positive test for Hepatitis C antibody with a detectable viral load on testing performed within one year of consent.
  • History of malignancy within the past 5 years that is not considered to be cured, with the exception of localized basal cell carcinoma of the skin (excised ≥ 2 years prior to randomization).
  • Evidence of severe liver disease with abnormal liver profile (aspartate aminotransferase (AST), alanine aminotransferase (ALT) or total bilirubin > 1.5 times upper limit of normal (ULN)) on testing performed within 30 days of consent.
  • Infection history: a)Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria). b) Hospitalization for treatment of infection within 60 days of Day 0. c) Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 60 days of Day 0.
  • Pregnant or nursing (lactating) women and women who might become pregnant during the study.
  • Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk.
  • Have a history of a primary immunodeficiency.
  • Have a significant IgG deficiency (IgG level < 400 mg/dl) or have an IgA deficiency (IgA level < 10 mg/dL).
  • Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0.
  • Have any other clinically significant abnormal laboratory value in the opinion of the investigator warrants exclusion of the subject from the trial.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Cincinnati

    Cincinnati, Ohio, 45267

Other trials in United States

About this study

Official title: Belimumab-Based Plasma Cell Targeted Therapy to Impact Transplant Eligibility

This study is a prospective, open label, phase I/II pilot study.

Read the detailed description

This study is a prospective, open label, phase I/II pilot study. For Treatment Groups A and B, the duration of study will include a 5 month enrollment period and approximately 7 months of follow-up. For Treatment Group C, the duration of study will include a 3 month enrollment period and approximately 7 months of follow-up.

Being tested
belimumab, Bortezomib, Rituximab, Plasmapheresis
Keywords
Transplantation, belimumab, Velcade

What participants receive

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

  • belimumabDrug

    Also called benlysta

    Belimumab will be administered per study protocol.

  • BortezomibDrug

    Also called Velcade

    Bortezomib will be administered per study protocol.

  • RituximabDrug

    Also called Rituxan

    Rituximab will be administered per study protocol.

  • PlasmapheresisDrug

    Plasmapheresis will be administered per study protocol.

Study groups in NCT02500251
Study groupRoleWhat they receive
Group A (5 subjects)ExperimentalSubjects will receive bortezomib and plasmapheresis.
Receives: Drug: Bortezomib; Drug: Plasmapheresis
Group B (5 subjects)ExperimentalSubjects will receive belimumab, bortezomib, and plasmapheresis.
Receives: Drug: belimumab; Drug: Bortezomib; Drug: Plasmapheresis
Group C (5 subjects)ExperimentalSubjects will receive belimumab, bortezomib, rituximab, and plasmapheresis.
Receives: Drug: belimumab; Drug: Bortezomib; Drug: Rituximab; Drug: Plasmapheresis

What is being measured

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

  1. Efficacy of belimumab as measured by percent reduction in iDSA and/or iAb

    Maximal percent reduction in immunodominant DSA (iDSA) [highest titer DSA (MFI)] and/or immunodominant antibody (iAb) from pre-treatment to Day 151.

    Measured: 7 months

Secondary outcomes (1)

  1. Safety of belimumab as measured by toxicities and peripheral neuropathy

    Overall safety of belimumab when used in the desensitization setting with bortezomib with or without rituximab (Incidence of grade 3 and above non-hematologic toxicities; Incidence of grade 4 hematologic toxicities; Incidence of all grades of peripheral neuropathy)

    Measured: 7 months

Timeline

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

  1. First posted16 Jul 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionJun 2018
  4. Study completionAug 2018

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02500251
Sponsor's protocol ID
Belimumab
Status last verified
Apr 2019
First submitted
9 Jul 2015
Last updated
22 Apr 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing belimumab, Bortezomib and Rituximab in people with Renal Transplant Rejection, run by E. Steve Woodle at 2 sites in United States.

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 8 inclusion and 23 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 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Efficacy of belimumab as measured by percent reduction in iDSA and/or iAb (time frame: 7 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 NCT02500251.

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 Apr 2019.

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