AzTrials
AzTrials

End Stage Kidney DiseasePhase 2NCT02475551

Study to Evaluate the Safety, Tolerability, Efficacy and PK of IdeS in Kidney Transplantation

A Phase 2 study testing IdeS in people with End Stage Kidney Disease, run by Hansa Biopharma AB at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will assess the safety and efficacy of IdeS in the transplantation setting. Each patient will receive one dose of IdeS. If the crossmatch test is negative at the time of transplantation, the patient will be transplanted with a kidney from a deceased or living donor. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End Stage Kidney Disease
What is being tested?
IdeS
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSweden
Study dates
Jun 2015to Oct 2016
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

  • Patients diagnosed with CKD and in dialysis with preformed anti-HLA antibodies (non-DSA, DSA or both), negative T-CDC CXM and at least one antibody MFI > 3000

Who cannot join

  • Prior malignancy within 2 years excluding adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ and prostate cancer Gleason <6 and prostate-specific antigen (PSA) <10 ng/mL.
  • Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV
  • Clinical signs of ongoing infectious disease.
  • Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure > New York Heart Association (NYHA) grade 3, unstable coronary disease or oxygen dependent chronic obstructive pulmonary disease (COPD)
  • History of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the study, or influence the results or the patient's ability to participate in the study
  • Hypogammaglobulinemia defined as any values of P-total IgG less than 3 g/L
Show all 9Show fewer
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to IdeS (e. g streptokinase and/or staphylokinase)
  • Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 4 months of the first administration of investigational product in this study.
  • Patients consented and screened but not dosed in previous studies are not excluded

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Hansa Medical AB

    Lund, 22007

Other trials in Sweden

About this study

Official title: A Phase II Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Intravenous Ascending Doses of IdeS in Kidney Transplantation

This study will assess the safety and efficacy of IdeS in the transplantation setting. Each patient will receive one dose of IdeS. If the crossmatch test is negative at the time of transplantation, the patient will be transplanted with a kidney from a deceased or living donor. The starting dose will be 0.25 mg/kg BW, given as a single intravenous infusion prior to surgery.

Read the detailed description

This study will assess the safety and efficacy of the IgG degrading cysteine protease IdeS in the transplantation setting. Patients with DSAs will be treated with IdeS prior to transplantation. Each patient will receive one dose of IdeS. If the crossmatch test is negative after IdeS treatment, the patient will be transplanted with a kidney from a deceased or living donor. Two to four dose groups are planned. Each group will contain 2 patients with the possibility to extend the group to up to 4 patients per group if required for safety and/or efficacy evaluation. The starting dose will be 0.25 mg/kg BW, given as a single intravenous infusion prior to surgery with the possibility to increase the dose in higher dose groups.

Being tested
IdeS
Medical subject headings
Kidney Failure, Chronic

What participants receive

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

  • IdeSDrug

    Intravenous infusion

Study groups in NCT02475551
Study groupRoleWhat they receive
TreatmentExperimentalIdeS as a single infusion
Receives: Drug: IdeS

What is being measured

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

  1. safety

    Adverse events, clinical laboratory tests, vital signs and ECGs

    Measured: 6 months

Secondary outcomes (1)

  1. Efficacy (mean fluorescent intensity (MFI) of less than 1100 as measured in an single antigen bead (SAB) assay)

    Efficacy defined as the IdeS dosing scheme resulting in anti human leucocyte antigen (HLA) antibody levels which are acceptable for transplantation, measured as an mean fluorescent intensity (MFI) of less than 1100 as measured in an single antigen bead (SAB) assay, within 24 hours from dosing

    Measured: 24 hours

Timeline

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

  1. First posted18 Jun 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionOct 2016
  4. Study completionOct 2016

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02475551
Sponsor's protocol ID
13-HMedIdeS-03
Status last verified
Jan 2018
First submitted
5 Jun 2015
Last updated
8 Jan 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Fernando SC, Polkinghorne KR, Lim WH, Mulley WR. Early Versus Late Acute AMR in Kidney Transplant Recipients-A Comparison of Treatment Approaches and Outcomes From the ANZDATA Registry. Transplantation. 2023 Nov 1;107(11):2424-2432. doi: 10.1097/TP.0000000000004700. Epub 2023 Jun 16.

    PubMed 37322595

  • 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 2 study testing IdeS in people with End Stage Kidney Disease, run by Hansa Biopharma AB at 1 site in Sweden.

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 1 inclusion and 9 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 8 Jan 2018. 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 Sweden. 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?

safety (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 NCT02475551, 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 8 Jan 2018.

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