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

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ClinicalTrials.gov Identifier: NCT04456816
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : September 22, 2021
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) who are on ACE inhibitor or angiotensin II receptor blocker treatment.

Condition or disease Intervention/treatment Phase
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) 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 4 weeks (28 days) as an add-on to any ongoing treatment, including ACE inhibitors/ angiotensin II receptor blocker
  • Group B (6 subjects): placebo for 4 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 4-week 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 4 Weeks as an add-on to Patients, in ACE Inhibitor or Angiotensin II Receptor Blocker Treatment, With Idiopathic Membranous Nephropathy
Actual Study Start Date : August 31, 2020
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: 100 mg AP1189
100 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
Drug: 100 mg AP1189
100 mg AP1189 powder in bottle. The dose of 100 mg AP1189 is selected as the starting dose, though with the opportunity to adjust the dose, based on a blinded evaluation of the pharmacokinetics results following dosing of the first 9 subjects.

Experimental: Placebo
Placebo. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension i e. the powder will be added 50 ml water.
Drug: Placebo
Placebo powder in bottle




Primary Outcome Measures :
  1. Adverse Event [ Time Frame: Week 4 ]
    Evaluation of Adverse Event

  2. Serious Adverse Events [ Time Frame: Week 4 ]
    Evaluation of Serious Adverse Events

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

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

  5. Total bilirubin change in plasma samples [ Time Frame: Week 4 ]
    Evaluation of total bilirubin compared with baseline

  6. Alkaline phosphatase change in plasma samples [ Time Frame: Week 4 ]
    Evaluation of alkaline phosphatase compared with baseline

  7. Protein change in 24 hours urinary protein excretion [ Time Frame: Week 4 ]
    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 4 ]
    Change of albumin in urine excretion compared to baseline measured in 24 h urinary protein excretion



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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 and based on a renal biopsy
  • Diagnosed as anti-PLA2-Receptor positive by local laboratory within 6 months prior to inclusion
  • Nephrotic syndrome defined by a U-protein/creatinine ratio >3.5 g/g and/or U-albumin/creatinine ratio >2.2 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 2 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
  • 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

Exclusion Criteria:

  • Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry
  • 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

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: September 22, 2021
Last Verified: September 2021

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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
Glomerulonephritis, Membranous
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases