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Renal DiseasePhase 1/2NCT02426684

Ides in Highly Sensitized (HS) Patients Awaiting Kidney Transplantation

A Phase 1/2 study testing IdeS® (Imlifidase) in people with Renal Disease, run by Cedars-Sinai Medical Center at 1 site 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 is a single center phase I/II open label, exploratory study assessing safety and efficacy of IdeS® (Hansa Medical, Lund, Sweden) given immediately prior to kidney transplantation. We hope that IdeS® will help eliminate DSAs in HS patients who are DSA+ and flow cytometry (FCMX) crossmatch + at time of transplant. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Renal Disease
What is being tested?
IdeS® (Imlifidase)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
16 Jun 2015to 10 Nov 2017
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • End-stage renal disease awaiting transplantation on the UNOS list.
  • No known contraindications for therapy with IVIG10%/Rituximab, plasmapheresis (PLEX) or IdeS®.
  • Age 18-70 years at the time of screening.
  • Calculated PRA (CPRA)> 50% demonstrated on 3 consecutive samples, Patient highly-HLA sensitized and a candidate for DD transplantation after desensitization at CSMC.
  • At transplant, patient must have donor-specific antibody/ crossmatch positive (DSA/CMX+) non-HLA identical donor.
  • Pre-transplant vaccination with Streptococcus pneumoniae and Nisseria meningitides
  • Subject/Parent/Guardian must be able to understand and provide informed consent.

Who cannot join

  • Positivity for anti-IdeS IgE
  • Use of IVIG 4 weeks prior to planned IdeS® administration
  • Recipients of Extended Criteria Donors (ECD) or Living Donors (LD)
  • Lactating or pregnant females.
  • Women of child-bearing age who are not willing or able to practice FDA-approved forms of contraception.
  • HIV-positive subjects.
Show all 28Show fewer
  • Subjects who test positive for HBV infection [positive HBVsAg, HBVcAb, or HBVeAg/DNA] or HCV infection [positive Anti-HCV (EIA) and confirmatory HCV RIBA].
  • Subjects with active TB.
  • Subjects with selective IgA deficiency, those who have known anti-IgA antibodies, and those with a history of anaphylaxis or severe systemic responses to any part of the clinical trial material.
  • Subjects who have received or for whom multiple organ transplants are planned.
  • Recent recipients of any licensed or investigational live attenuated vaccine(s) within two months of the screening visit (including but not limited to any of the following:
  • Adenovirus [Adenovirus vaccine live oral type 7]
  • Varicella [Varivax]
  • Hepatitis A [VAQTA]
  • Rotavirus [Rotashield]
  • Yellow fever [Y-F-Vax]
  • Measles and mumps [Measles and mumps virus vaccine live]
  • Measles, mumps, and rubella vaccine [M-M-R-II]
  • Sabin oral polio vaccine
  • Rabies vaccines [IMOVAX Rabies I.D., RabAvert])
  • A significantly abnormal general serum screening lab result defined as a WBC < 3.0 X 103/ml, a Hgb < 8.0 g/dL, a platelet count < 100 X 103/ml, , an SGOT > 3X upper limit .
  • Individuals deemed unable to comply with the protocol.
  • Subjects with active CMV or EBV infection as defined by CMV-specific serology (IgG or IgM) and confirmed by quantitative PCR with or without a compatible illness.
  • Subjects with a known history of previous myocardial infarction within one year of screening.
  • Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.
  • Subjects with Protein C and Protein S deficiency
  • Use of investigational agents within 4 weeks of participation.
  • Known allergy/sensitivity to IdeS® infusions

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

Official title: A Phase I/II Trial to Evaluate the Safety and Tolerability of Ides® (IgG Endopeptidase) to Eliminate Donor Specific HLA Antibodies (DSAs) and Prevent Antibody-Mediated Rejection Post-Transplant in Highly-HLA Sensitized Patients.

This is a single center phase I/II open label, exploratory study assessing safety and efficacy of IdeS® (Hansa Medical, Lund, Sweden) given immediately prior to kidney transplantation. We hope that IdeS® will help eliminate DSAs in HS patients who are DSA+ and flow cytometry (FCMX) crossmatch + at time of transplant. We plan to enroll a total of 20 patients. Patients will be followed for 6 months post administration of IdeS®.

Read the detailed description

IdeS® is an IgG-degrading enzyme of S.pyogenes that cleaves all four human subclasses of IgG with strict specificity. Alloantibodies are a major deterrent to access to and success of life-saving organ transplants. We hypothesize that the use of IdeS® pre-transplant in HS patients will represent a more robust and complete technique to eliminate DSA from the sera of HS patients. A single dose administration of IdeS® in the pre-operative period to HS patients with positive DSAs and flow cytometry crossmatches will durably eliminate circulating DSAs, allow transplantation to occur without ABMR and, in conjunction with standard desensitization therapy, result in a durable suppression of DSA levels thus eliminating the risk for ABMR.

Conditions
Renal Disease
Being tested
IdeS® (Imlifidase)
Keywords
End Stage Renal Disease, Kidney Transplant, Desensitization, Highly Sensitized, Antibodies
Medical subject headings
Kidney Diseases, Kidney Failure, Chronic

What participants receive

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

  • IdeS® (Imlifidase)Drug

    Also called IgG endopeptidase

    0.24mg/kg IdeS

Study groups in NCT02426684
Study groupRoleWhat they receive
IdeS®ExperimentalTwenty patients will receive 0.24mg/kg (n=20)
Receives: Drug: IdeS® (Imlifidase)

What is being measured

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

  1. Number of Participants With Allograft Rejection

    Number of participants with allograft rejection will be assessed at 6 month post transplant renal biopsy.

    Measured: 6 months

Secondary outcomes (3)

  1. eGFR

    eGFR based on serum creatinine will be collected 6 months post transplant.

    Measured: 6 months post transplant

  2. Proteinuria

    Urine total protein \& urine creatinine will be drawn from day 0 to day 30, and urinalysis will be collected on day 180 from transplant.

    Measured: 6 months post transplant

  3. Number of Participants With Donor Specific Antibodies (DSA) Post-transplant

    Donor specific antibody levels will be checked at Day 180 post transplant to see if patients developed new antibodies or antibody intensity levels worsened post transplant. The DSA mean fluorescence intensity (MFI) was recorded, in comparison to the levels at transplant. This outcome measure was intended to record if any of the participants had a new DSA formation at Day 180, or if any participant had higher MFI levels of the DSA at Day 180, compared to baseline.

    Measured: 6 months post transplant

Timeline

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

  1. First posted27 Apr 2015 (estimated)
  2. Study start16 Jun 2015
  3. Primary completion10 Nov 2017
  4. Study completion10 Nov 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02426684
Sponsor's protocol ID
IdeSCSMC
Status last verified
Apr 2022
First submitted
22 Apr 2015
Last updated
16 May 2022
Data monitoring committee
Yes

Publications

  • von Pawel-Rammingen U. Streptococcal IdeS and its impact on immune response and inflammation. J Innate Immun. 2012;4(2):132-40. doi: 10.1159/000332940. Epub 2012 Jan 17.

    PubMed 22248585

  • Jordan SC, Lorant T, Choi J, Kjellman C, Winstedt L, Bengtsson M, Zhang X, Eich T, Toyoda M, Eriksson BM, Ge S, Peng A, Jarnum S, Wood KJ, Lundgren T, Wennberg L, Backman L, Larsson E, Villicana R, Kahwaji J, Louie S, Kang A, Haas M, Nast C, Vo A, Tufveson G. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med. 2017 Aug 3;377(5):442-453. doi: 10.1056/NEJMoa1612567.

    PubMed 28767349

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IdeS® (Imlifidase) in people with Renal Disease, run by Cedars-Sinai Medical Center at 1 site 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 7 inclusion and 28 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 16 May 2022. 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 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?

Yes. Results are posted in the registry (first posted 16 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Allograft Rejection (time frame: 6 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 NCT02426684, 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 16 May 2022.

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