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A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria

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ClinicalTrials.gov Identifier: NCT04456816
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
SynAct Pharma Aps

Brief Summary:
This study is an exploratory, randomized, double-blind, multicenter, placebo-controlled study with repeated doses of AP1189. The study population will consist of patients with idiopathic membranous nephropathy (iMN) and severe proteinuria who are on ACE inhibitor or angiotensin II receptor blocker treatment.

Condition or disease Intervention/treatment Phase
Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy Severe Proteinuria Due to Idiopathic Membranous Nephropathy Drug: 100 mg AP1189 Drug: Placebo Phase 2

Detailed Description:

This study is an exploratory, randomized, double-blind, multicenter, placebo-controlled study with repeated doses of AP1189. The study population will consist of patients with idiopathic membranous nephropathy (iMN) and severe proteinuria who are on ACE inhibitor or angiotensin II receptor blocker treatment.

Following a successful screening, subjects who fulfill the enrollment criteria will be randomized in a 2:1 ratio in group A and B:

  • Group A (12 subjects): AP1189 dose 100 mg, once daily for 12 weeks (28 days) as an add-on to any ongoing treatment, including ACE inhibitors/ angiotensin II receptor blocker
  • Group B (6 subjects): placebo for 12 weeks (28 days) as an add-on to any ongoing treatment including ACE inhibitors/ angiotensin II receptor blocker.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Exploratory, randomized, double-blind, multi-center, placebo-controlled 12-weeks study with repeated doses of AP1189
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Exploratory, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AP1189 Versus Placebo Administered for 12 Weeks as an add-on to Patients, in ACE Inhibitor or Angiotensin II Receptor Blocker Treatment, With Idiopathic Membranous Nephropathy and Severe Proteinuria
Actual Study Start Date : August 31, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Experimental: 100 mg AP1189
100 mg AP1189. The treatment is a 12-weeks treatment. Each daily dose will be administered as a tablet
Drug: 100 mg AP1189
100 mg AP1189 tablet

Experimental: Placebo
Placebo. The treatment is a 12-weeks treatment. Each daily dose will be administered as a tablet
Drug: Placebo
Matching placebo tablet




Primary Outcome Measures :
  1. Adverse Event [ Time Frame: Week 12 ]
    Evaluation of Adverse Event

  2. Serious Adverse Events [ Time Frame: Week 12 ]
    Evaluation of Serious Adverse Events

  3. ALAT change in plasma samples [ Time Frame: Week 12 ]
    Evaluation of ALAT compared with baseline

  4. ASAT change in plasma samples [ Time Frame: Week 12 ]
    Evaluation of ASAT compared with baseline

  5. Total bilirubin change in plasma samples [ Time Frame: Week 12 ]
    Evaluation of total bilirubin compared with baseline

  6. Alkaline phosphatase change in plasma samples [ Time Frame: Week 12 ]
    Evaluation of alkaline phosphatase compared with baseline

  7. Protein change in 24 hours urinary protein excretion [ Time Frame: Week 12 ]
    Change of protein in urine excretion compared to baseline measured in 24 h urinary protein excretion


Secondary Outcome Measures :
  1. Albumin change in 24 hours urinary protein excretion [ Time Frame: Week 12 ]
    Change of albumin in urine excretion compared to baseline measured in 24 h urinary protein excretion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent has been obtained prior to initiating any study-specific procedures
  • Male and female subjects, 18 to 85 years of age diagnosed with iMN within 6 months prior to inclusion
  • Diagnosed as anti-PLA2-Receptor positive by local laboratory within 6 months prior to inclusion
  • Severe proteinuria defined by a U-protein/creatinine ratio >3.0 g/g and/or U-albumin/creatinine ratio >2.0 g/g and a P-albumin below the lower normal limit
  • eGFR > 30 ml/min/1.73m2
  • Treated with ACE- inhibitors or angiotensin II receptor blocker for a minimum of 1 months with a stable systemic arterial blood pressure OR treatment with ACE inhibitors and/or angiotensin receptor blocker was excluded or discontinued due to hypotension, intolerance or other side effect

Only Denmark and Norway:

  • Females of child-bearing potential using reliable means of contraception or are post-menopausal
  • Females of childbearing potential with negative pregnancy test at screening and baseline

Only Sweden:

  • Post-menopausal women or women who are surgically sterilized.

Exclusion Criteria:

  • Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry
  • Clinicial findings that in the opinion of the investigator would suggest condition(s) other than iMN as a major cause of severe proteinuria
  • Major surgery within 8 weeks prior to screening or planned surgery within 1 month following randomization
  • Blood pressure with systolic pressure above 160 mmHg and/or diastolic pressure above 100 mmHg despite antihypertensive treatment will in all cases be considered "uncontrolled"
  • Treated with systemic corticosteroids, or other immune suppressive, or immune modulating compounds within 4 weeks prior to screening and during the entire treatment period and until the final visit
  • Treated with rituximab within 12 months of screening
  • Evidence of active malignant disease
  • Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
  • Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disease
  • Pregnant women or nursing mothers
  • History of alcohol, drug, or chemical abuse within the 6 months prior to screening
  • Any condition that in the view of the investigator would suggest that the patient is unable to comply with study protocol and procedures

Only Sweden:

  • Females of child-bearing potential.

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): NCT04456816


Contacts
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Contact: Irene Sandholdt +45 2015 7033 isa@croxxmed.com
Contact: Birgitte Telmer, MD +45 2015 1221 bte@croxxmed.com

Locations
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Denmark
Aarhus Universitetshospital Recruiting
Aarhus, Denmark, 8200
Contact: Henrik Birn, Professor    +45 40460271    henrbirn@rm.dk   
Sponsors and Collaborators
SynAct Pharma Aps
Investigators
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Principal Investigator: Henrik Birn, Professor Aarhus Universitetshospital
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Responsible Party: SynAct Pharma Aps
ClinicalTrials.gov Identifier: NCT04456816    
Other Study ID Numbers: SynAct-CS003
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022

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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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Kidney Diseases
Proteinuria
Nephrotic Syndrome
Nephrosis
Glomerulonephritis, Membranous
Urologic Diseases
Urination Disorders
Urological Manifestations
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases