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An Open-Label Phase II Study to Evaluate the Efficacy and Safety of IdeS in Anti-GBM Disease (GOOD-IDES) (GOOD-IDES)

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ClinicalTrials.gov Identifier: NCT03157037
Recruitment Status : Unknown
Verified May 2017 by Mårten Segelmark, Linkoeping University.
Recruitment status was:  Recruiting
First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
Hansa Biopharma AB
Information provided by (Responsible Party):
Mårten Segelmark, Linkoeping University

Brief Summary:
This study will evaluate the safety and tolerability of IdeS in patients with severe anti-GBM (Glomerular Basement Membrane) disease receiving standard care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide combined with plasma exchange (PLEX).

Condition or disease Intervention/treatment Phase
Anti-Glomerular Basement Membrane Disease Biological: HMed-IdeS Phase 2

Detailed Description:
This is an Open-Label Phase 2 Study to Evaluate the Efficacy and Safety of IdeS in anti-GBM disease (Goodpasture's disease, i.e. GP) with Adverse Renal Prognosis. The primary efficacy objective is to evaluate the efficacy of an IdeS based regimen to salvage independent renal function measured as no need for dialysis at 6 months after IdeS treatment. The primary safety objective of this study is to evaluate the safety and tolerability of IdeS in patients with severe anti-GBM disease on background of standard care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide (CYC) combined with plasma exchange (PLEX). The patients will be followed during 6 months according to the study visit plan.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-Label, Single Arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase II Study in Anti-GBM Disease (Goodpasture's Disease) With Adverse Renal Prognosis to Evaluate the Efficacy and Safety of IdeS --GOOD-IDES
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment HMed-IdeS
IdeS intravenous infusion 0.25 mg/kg BW intravenous infusion
Biological: HMed-IdeS
One dose of 0.25 mg/kg BW HMed-IdeS on study day 1
Other Name: Immunoglobulin G-degrading enzyme of Streptococcus pyogenes




Primary Outcome Measures :
  1. Proportion of patients with independent renal function at 6 months [ Time Frame: 6 months after dosing ]
    Number of patients without need for dialysis


Secondary Outcome Measures :
  1. The proportion of subjects with independent renal function, defined as no need for dialysis at 3 months, as compared to historical controls. [ Time Frame: 3 months after dosing ]
    Number of patients without need for dialysis

  2. Renal function at 3 and 6 months [ Time Frame: 3 and 6 months after dosing ]
    eGFR and change in GFR from baseline;

  3. Number of days with anti-GBM antibodies above a toxic level [ Time Frame: 6 months after dosing ]
    Days with anti-GBM antibodies >30 ELISA units

  4. Disappearance of haematuria [ Time Frame: 6 months after dosing ]
    Number of days until disappearance of haematuria, measured in days from start of treatment

  5. Change in proteinuria during the study [ Time Frame: 6 months after dosing ]
    Change in proteinuria during the study measured as u-albumin/creatinine ratio in morning void

  6. Number of PLEXs needed [ Time Frame: 6 months after dosing ]
    Number of PLEXs needed before anti-GBM antibodies are below toxic levels

  7. Renal histology [ Time Frame: 6 months after dosing ]
    Renal histology measurements and changes in renal histology if a second renal biopsy is performed

  8. Anti-IdeS antibodies (ADA) [ Time Frame: 6 months after dosing ]
    Determination of anti-IdeS antibody concentration

  9. Pharmacodynamics (IgG degradation) [ Time Frame: Day 0 to day 28 after dosing ]
    Determination of IgG and determination of IgG fragments

  10. Pharmacokenetics [ Time Frame: Day 0 to day 14 after dosing ]
    Area under the plasma concentration versus time curve (AUC)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Anti-GBM antibodies detected by ELISA above a level that is considered toxic by the investigator using local laboratory. Patients double-positive for anti-GBM and ANCA may be entered in the trial, but only if their level of anti-GBM antibodies fulfil the criteria listed above.
  2. eGFR < 15 ml/min/1.73 m2 (by MDRD equation) or if the patient is non-responsive to standard treatment, and has lost >15 ml/min/1.73 m2 after start of treatment
  3. Haematuria on dipstick and/or urinary sediment
  4. Male or female patients aged at least 18 years; Female patients of childbearing potential may participate if highly effective contraception is used during the study, according to CTFG guidance [18], see also section 4.9 (pregnancy test should be performed before inclusion).
  5. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol; and
  6. Judged to be otherwise healthy by the Investigator, based on medical history, physical examination, and clinical laboratory assessments. Patients with clinical laboratory values that are outside of normal limits (other than those specified in the Exclusion Criteria) and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance, may be entered into the study.

Exclusion Criteria:

  1. Anuria for more than 2 days (less than 200 ml during last 48 hours);
  2. Dialysis dependency for more than 5 days (maximum 3 sessions before signing informed consent);
  3. Ongoing moderate to severe pulmonary haemorrhage (or having ceased within the last two weeks), defined as requiring assisted ventilation, oxygen or blood transfusions.
  4. Pregnancy.
  5. Symptomatic congestive heart failure (NYHA class 2-4) and requiring prescription medication or clinically evident peripheral edema of cardiac origin;
  6. Myocardial infarction, unstable angina or stroke within 3 months prior to screening;
  7. Ongoing bacterial infection requiring antibiotic therapy or viral infection with Hepatitis B, C or HIV (up to 3 months old negative test results are accepted); or active tuberculosis as indicated by chest x-ray.
  8. Patients should not have received investigational drugs within 30 days prior to screening or within 4 half-lives (whichever is longer); and
  9. History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157037


Contacts
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Contact: Mårten Segelmark, MD PhD Prof +46 10 1032297 marten.segelmark@liu.se
Contact: Fredrik Uhlin, RN PhD Prof +46 10 103 1804 fredrik.uhlin@regionostergotland.se

Locations
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Sweden
Department of Nephrology, University Hospital, Recruiting
Linkoping, Sweden, SE-581 85
Contact: Anders Fernström, Ass. Prof MD    +46 10 103 86 47    anders.fernstrom@regionostergotland.se   
Contact: Micael Gylling, RN    46 10 103 1805    micael.gylling@regionostergotland.se   
Sponsors and Collaborators
Mårten Segelmark
Hansa Biopharma AB
Investigators
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Principal Investigator: Mårten Segelmark, MD PhD Prof Linkoeping University

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Responsible Party: Mårten Segelmark, MD, PhD and Professor Department of Drug Research, Department of Medical and Health Sciences, Linkoeping University
ClinicalTrials.gov Identifier: NCT03157037     History of Changes
Other Study ID Numbers: GOOD-IDES-01
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anti-Glomerular Basement Membrane Disease
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs