AzTrials
AzTrials

Kidney Transplant CandidatesPhase 2LIVEDESNCT06461546

Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients

A Phase 2 study testing Imlifidase in people with Kidney Transplant Candidates, run by Fundacion Clinic per a la Recerca Biomédica.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This is a Phase II, pilot, prospective, unicentric trial, to evaluate Imlifidase could improve the transplantability of the highly sensitized patients with good outcomes respect to survival and functionality of the graft. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Kidney Transplant Candidates
What is being tested?
Imlifidase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
22 Oct 2024to May 2027
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Participants who meet any of the following criteria will be excluded from participation in this study:
  • Participant Exclusion Criteria
  • Known contraindications for therapy with IVIG, Rituximab, plasma exchange (PLEX) or Imlifidase.
  • Recipients of Deceased Donors (DBD, Extended Criteria Donors (ECD) or DCD).
  • A positive Complement-Dependent Cytotoxicity (CDC) Crossmatch against the living donor.
  • HIV-positive subjects.
Show all 19Show fewer
  • Subjects who test positive for HBV infection [positive HBVsAg or HBVeAg/DNA] or HCV infection [RNA+].
  • 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.
  • A significantly abnormal general serum screening lab result defined as WBC<3.0x103/ml, Hgb<8.0 g/dL, platelet count <100x103/ml, SGOT>3xupper limit.
  • Subjects with active CMV or EBV infection as defined by positive PCR.
  • 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.
  • Patients with a kidney disease with high risk of recurrence and/or complement-associated kidney disease (aHUS, etc).
  • Subjects with Protein C and Protein S deficiency.
  • Pregnant and lactating women
  • Current diagnosis or history of thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP.
  • Known allergy to Imlifidase or excipient of the drug preparation

About this study

Official title: Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients (LIVEDES)

This is a Phase II, pilot, prospective, unicentric trial, to evaluate Imlifidase could improve the transplantability of the highly sensitized patients with good outcomes respect to survival and functionality of the graft.

Read the detailed description

The patients between 18 and 65 years will be flow cytometry crossmatch (FC-XM) positive against an available living donor. The imlifidase treatment will turn the crossmatch test negative prior to transplantation. A second dose of imlifidase can be given within 24 hours if the first dose is considered not to have sufficient effect. If a second dose is given, a confirmatory FCXM test will be performed pre-second imlifidase dosing and between 2-6 hours following the second dose.

Being tested
Imlifidase
Keywords
living kidney trasplant, imlifidase treatment

What participants receive

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

  • ImlifidaseDrug

    • Imlifidase (POD0, pre-transplantation), imlifidase, 0.25 mg/kg over a period of 15 minutes, prior to transplantation.
    • Dose Adjustment Criteria

    FC-XM screening and single antigen will be performed after 6 hours of imlifidase infusion, It will take 3 hours to obtain the results, respectively:

    • NEGATIVE (FC-XM) - renal transplantation will be performed as soon as possible.
    • POSITIVE (FC-XM) - 2nd Imlifidase infusion will be required (imlifidase dose: 0.25mg/Kg).

    FC-XM screening and single antigen will be performed after 2 hours of the 2nd Imlifidase infusion:

    • NEGATIVE (FC-XM) - renal transplantation will be performed as soon as possible.
    • POSITIVE (FC-XM) - The scheduled kidney transplant will be canceled.
Study groups in NCT06461546
Study groupRoleWhat they receive
Imlifidase treatmentExperimentalSingle arm pilot study All highly sensitized patients included in the study will receive the immunosuppressive standard of care therapy at Hospital Clínic de Barcelona and in addition the study drug: * Imlifidase (POD0, pre-transplantation), imlifidase, 0.25 mg/kg over a period of 15 minutes, prior to transplantation. * Dose Adjustment Criteria FC-XM screening and single antigen will be performed after 6 hours of imlifidase infusion, It will take 3 hours to obtain the results, respectively: * NEGATIVE (FC-XM) - renal transplantation will be performed as soon as possible. * POSITIVE (FC-XM) - 2nd Imlifidase infusion will be required (imlifidase dose: 0.25mg/Kg). FC-XM screening and single antigen will be performed after 2 hours of the 2nd Imlifidase infusion: * NEGATIVE (FC-XM) - renal transplantation will be performed as soon as possible. * POSITIVE (FC-XM) - The scheduled kidney transplant will be canceled.
Receives: Drug: Imlifidase

What is being measured

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

  1. • Proportion of patients with conversion of a positive virtual crossmatch to negative within 6 hours after imlifidase treatment (up to two doses).

    The fraction of patients with a conversion of a positive FC-XM within 6 hours of treatment with imlifidase.

    Measured: 6 hours

Secondary outcomes (12)

  1. 1. Proportion of patients that require a second dose of imlifidase

    To evaluate flow cytometry T-cell crossmatch conversion within 24 hours of imlifidase treatment, requirement of a second dose of imlifidase.

    Measured: 24 hours

  2. 2. To evaluate the rebound of preexisting donor specific antibodies (DSA) (difference between MFI of each DSA daily - until D+14 - compared to pre-imlifidase administration)

    Pre-existing DSA appearance measured daily until D+14

    Measured: daily, from day 0 to day 14

  3. 3. De novo DSA appearance over 14 days after imlifidase treatment

    To evaluate the appearance of de novo DSAs (any DSA no present in pre-transplant or historical) daily - until D+14. To be considered positive the bead MFI should be over 750 and to be above the bead specific threshold related to the lowest bead of the same locus.

    Measured: daily, from day 0 to day 14

  4. 4. To evaluate HLA/DSA antibody levels up to 1 year after transplantation

    HLA/DSA antibody levels at several time points between pre-dose imlifidase and 2 weeks, and at 1, 3 and 6 months and 1 year after imlifidase treatment

    Measured: time points between pre-dose imlifidase and 2 weeks, and at 1, 3 and 6 months and 1 year after imlifidase treatment

  5. 5. To evaluate renal function up to 1 year after transplantation

    by estimated glomerular filtration rate (eGFR) and serum/plasma creatinine levels

    Measured: time points between 24 hours and 2 weeks and at 1, 3 and 6 months and 1 year after transplantation as assessed

  6. 6. To evaluate patient survival 1 year after transplantation

    Patient survival at 12 months after transplantation

    Measured: at 12 months after transplantation

  7. 7. To evaluate the graft survival at 12 months

    To evaluate the graft survival at 12 months (both overall and death-censored analysis).

    Measured: at 12 months after transplantation

  8. 8. Proportion of patients with biopsy confirmed rejection, either cell-mediated or antibody-mediated rejection, over 1 year

    To evaluate the incidence of acute allograft rejection within 12 months (overall and stratified by type: cell mediated rejection or antibody-mediated rejection

    Measured: within 12 months

  9. 9. To evaluate safety of Imlifidase treatment with regards to infusion related reactions occurring within 48 hours of Imlifidase infusion

    Proportion of patients with infusion-related reactions within 48 hours of Imlifidase infusion

    Measured: within 48 hours of Imlifidase infusion

  10. 10.adverse events within 30 days after transplantation

    Proportion of patients with adverse events within 30 days after transplantation

    Measured: 30 days after transplantation

  11. 11. Proportion of patients with severe or serious infections

    To evaluate the adverse events ( infectious disease that required hospitalization) at 6 and 12 months.

    Measured: 6 months and 12 months

  12. 12. To evaluate safety of Imlifidase treatment with regards to reported serious adverse events (SAEs)

    Safety over 1 year as measured by reported SAEs

    Measured: 12 months

Timeline

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

  1. First posted17 Jun 2024
  2. Study start22 Oct 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Why it stopped: Inability to provide study drug to participants

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
Model description
Phase II, prospective, single arm pilot study. To evaluate the ability of Imlifidase treatment to achieve a negative virtual crossmatch in patients with available live donor kidney.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06461546
Sponsor's protocol ID
LIVEDES study
Other IDs
2024-513607-14-00
Acronym
LIVEDES
Status last verified
Dec 2024
First submitted
11 Jun 2024
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imlifidase in people with Kidney Transplant Candidates, run by Fundacion Clinic per a la Recerca Biomédica.

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 0 inclusion and 19 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: withdrawn, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

• Proportion of patients with conversion of a positive virtual crossmatch to negative within 6 hours after imlifidase treatment (up to two doses). (time frame: 6 hours). 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 NCT06461546.

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 12 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in