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Diabetes MellitusPhase 2ICCNCT02727608

Complement Inhibitor Eculizumab in Clinical Islet Transplantation

A Phase 2 study testing Eculizumab in people with Diabetes Mellitus, run by Uppsala University 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
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Trial summary

This is a dual centre, single arm, exploratory study of the possibility to use eculizumab (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the islets in patients with diabetics accepted for islet transplant. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Eculizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteSweden
Study dates
15 May 2016to Jun 2018
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

  • Patients between 18 to 65 years of age
  • Patients able to provide written informed consent
  • Absent stimulated c-peptide (< 0.1 nmol/L). This includes also previously islet-transplanted patients with no detectable c-peptide.
  • Patients at fear of severe hypoglycemia
  • Female patients of child bearing potential must have a negative pregnancy test (s-β-HCG) and must be practicing an effective, reliable medical accepted contraceptive regimen while on eculizumab treatment and to study end at 75 days.
  • Patients vaccinated against Neisseria meningitides or patients accepting adequate antibiotic prophylaxis

Who cannot join

  • Body mass index > 30 kg/m2
  • Untreated proliferative diabetes retinopathy
  • Recipient of any other concomitant organ transplantation - Glomerular filtration rate < 50 mL/min before first islet transplantation
  • Positive T-cell cross-matching by Complement Depending Cytotoxicity (CDC)
  • Pregnancy or lactating
  • Active ongoing infection, bacterial or viral
Show all 11Show fewer
  • Unresolved meningococcal disease
  • Known bleeding disorder
  • Known complement disorder
  • Have received any other investigational drug within 30 days before inclusion
  • History of drug or alcohol abuse within the last year

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Dept of Surgical Sciences, Section of Transplantation Surgery, University Hospital

    Uppsala, 752 37

Other trials in Sweden

About this study

Official title: Induction With Complement Inhibitor Eculizumab in Clinical Islet Transplantation

This is a dual centre, single arm, exploratory study of the possibility to use eculizumab (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the islets in patients with diabetics accepted for islet transplant.

Read the detailed description

This is a dual centre, single arm, exploratory study of the possibility to use eculizumab (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the islets in patients with diabetics accepted for islet transplant. Ten patients from 2 centres (Uppsala University Hospital and Karolinska University Hospital in Stockholm) will be transplanted. The purpose of the study is to investigate if selective complement inhibition by eculizumab combined with standard anticoagulation during and after transplantation can further reduce the extent of early tissue loss after portal infusion of islets.

Being tested
Eculizumab
Medical subject headings
Diabetes Mellitus

What participants receive

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

  • EculizumabDrug

    Also called Soliris

    Intravenous infusion (1200 mg) over 35 minutes. Consecutive infusions (900 mg) on Days 1, 7 and 14.

Study groups in NCT02727608
Study groupRoleWhat they receive
EculizumabExperimentalIntravenous infusion
Receives: Drug: Eculizumab

What is being measured

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

  1. Increased survival of ICC´s transplanted as measured by peak c-peptide

    Determined by PET-scan of 2-deoxy-27fluoro-D-glucose (18F) (FDG)-labelled islets infused in the portal vein.

    Measured: During and within two hours post infusion (day 0).

Secondary outcomes (7)

  1. Effect of eculizumab on instant blood mediated inflammatory reaction (IBMIR) as determined by complement activation.

    Extent of early tissue loss

    Measured: At the end of infusion and 1 and 2 h post start of infusion (day 0).

  2. Monitoring of islet-function and survival.

    Evaluation of insulin-independency, the extent of reduction of baseline insulin requirement, continuous glucose monitoring system (CGMS) performance, HbA1c, number of hypoglycemic events per week.

    Measured: 14, 30 and 75 days post-transplant.

  3. Adverse events (AEs) and serious adverse events (SAEs)

    Will be assigned Medical Drug Regulatory Activities (MedDRA) preferred terms and tabulated as incidence rate

    Measured: From start of infusion until 75 days post-transplant.

  4. Patient and graft survival at 75 days post treatment.

    Graft survival is measured by measurable stimulated c-peptide (>0,1 nmol/L)

    Measured: From start of infusion until 75 days post-transplant.

  5. Estimated glomerular filtration rate (GFR) (Cystatin C)

    Cystatin C value

    Measured: At day 75

  6. Portal vein thrombosis

    Assessment by per protocol ultrasound

    Measured: The day after infusion

  7. Bleeding

    will be assessed by hemoglobin and thrombocyte monitoring (important while portal vein catheter is in place and withdrawn (within first week).

    Measured: From infusion until 2 hours post start of infusion

Timeline

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

  1. First posted4 Apr 2016 (estimated)
  2. Study start15 May 2016
  3. Primary completionMay 2018
  4. Study completionJun 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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02727608
Sponsor's protocol ID
ICC version 2
Other IDs
2014-005421-12, 2014
Acronym
ICC
Status last verified
Oct 2018
First submitted
29 Mar 2016
Last updated
4 Oct 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Ryan EA, Paty BW, Senior PA, Bigam D, Alfadhli E, Kneteman NM, Lakey JR, Shapiro AM. Five-year follow-up after clinical islet transplantation. Diabetes. 2005 Jul;54(7):2060-9. doi: 10.2337/diabetes.54.7.2060.

    PubMed 15983207

  • Eich T, Eriksson O, Lundgren T; Nordic Network for Clinical Islet Transplantation. Visualization of early engraftment in clinical islet transplantation by positron-emission tomography. N Engl J Med. 2007 Jun 28;356(26):2754-5. doi: 10.1056/NEJMc070201. No abstract available.

    PubMed 17596618

  • Eich T, Eriksson O, Sundin A, Estrada S, Brandhorst D, Brandhorst H, Langstrom B, Nilsson B, Korsgren O, Lundgren T. Positron emission tomography: a real-time tool to quantify early islet engraftment in a preclinical large animal model. Transplantation. 2007 Oct 15;84(7):893-8. doi: 10.1097/01.tp.0000284730.86567.9f.

    PubMed 17984843

  • Moberg L, Johansson H, Lukinius A, Berne C, Foss A, Kallen R, Ostraat O, Salmela K, Tibell A, Tufveson G, Elgue G, Nilsson Ekdahl K, Korsgren O, Nilsson B. Production of tissue factor by pancreatic islet cells as a trigger of detrimental thrombotic reactions in clinical islet transplantation. Lancet. 2002 Dec 21-28;360(9350):2039-45. doi: 10.1016/s0140-6736(02)12020-4.

    PubMed 12504401

  • Bennet W, Sundberg B, Groth CG, Brendel MD, Brandhorst D, Brandhorst H, Bretzel RG, Elgue G, Larsson R, Nilsson B, Korsgren O. Incompatibility between human blood and isolated islets of Langerhans: a finding with implications for clinical intraportal islet transplantation? Diabetes. 1999 Oct;48(10):1907-14. doi: 10.2337/diabetes.48.10.1907.

    PubMed 10512353

  • Koh A, Senior P, Salam A, Kin T, Imes S, Dinyari P, Malcolm A, Toso C, Nilsson B, Korsgren O, Shapiro AM. Insulin-heparin infusions peritransplant substantially improve single-donor clinical islet transplant success. Transplantation. 2010 Feb 27;89(4):465-71. doi: 10.1097/TP.0b013e3181c478fd.

    PubMed 20177350

  • Eriksson O, Eich T, Sundin A, Tibell A, Tufveson G, Andersson H, Felldin M, Foss A, Kyllonen L, Langstrom B, Nilsson B, Korsgren O, Lundgren T. Positron emission tomography in clinical islet transplantation. Am J Transplant. 2009 Dec;9(12):2816-24. doi: 10.1111/j.1600-6143.2009.02844.x. Epub 2009 Oct 21.

    PubMed 19845588

  • Friberg AS, Brandhorst H, Buchwald P, Goto M, Ricordi C, Brandhorst D, Korsgren O. Quantification of the islet product: presentation of a standardized current good manufacturing practices compliant system with minimal variability. Transplantation. 2011 Mar 27;91(6):677-83. doi: 10.1097/TP.0b013e31820ae48e.

    PubMed 21248660

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eculizumab in people with Diabetes Mellitus, run by Uppsala University 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 6 inclusion and 11 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 4 Oct 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?

Increased survival of ICC´s transplanted as measured by peak c-peptide (time frame: During and within two hours post infusion (day 0).). 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 NCT02727608, which also lists 8 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 4 Oct 2018.

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