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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 24, 2020
First Posted Date  ICMJE July 7, 2020
Last Update Posted Date September 22, 2021
Actual Study Start Date  ICMJE August 31, 2020
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2020)
  • Adverse Event [ Time Frame: Week 4 ]
    Evaluation of Adverse Event
  • Serious Adverse Events [ Time Frame: Week 4 ]
    Evaluation of Serious Adverse Events
  • ALAT change in plasma samples [ Time Frame: Week 4 ]
    Evaluation of ALAT compared with baseline
  • ASAT change in plasma samples [ Time Frame: Week 4 ]
    Evaluation of ASAT compared with baseline
  • Total bilirubin change in plasma samples [ Time Frame: Week 4 ]
    Evaluation of total bilirubin compared with baseline
  • Alkaline phosphatase change in plasma samples [ Time Frame: Week 4 ]
    Evaluation of alkaline phosphatase compared with baseline
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2020)
  • Adverse Event [ Time Frame: Week 4 ]
    Evaluation of Adverse Event
  • Serious Adverse Events [ Time Frame: Week 4 ]
    Evaluation of Serious Adverse Events
  • Laboratorie assessment ALAT [ Time Frame: Week 4 ]
    Evaluation of ALAT compared with baseline
  • Laboratorie assessment ASAT [ Time Frame: Week 4 ]
    Evaluation of ASAT compared with baseline
  • Laboratorie assessment total bilirubin [ Time Frame: Week 4 ]
    Evaluation of total bilirubin compared with baseline
  • Laboratorie assessment alkaline phosphatase [ Time Frame: Week 4 ]
    Evaluation of alkaline phosphatase compared with baseline
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2020)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Idiopathic Membranous Nephropathy
Intervention  ICMJE
  • 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.
  • Drug: Placebo
    Placebo powder in bottle
Study Arms  ICMJE
  • 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.
    Intervention: Drug: 100 mg AP1189
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2020)
23
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Irene Sandholdt +45 2015 7033 isa@croxxmed.com
Contact: Birgitte Telmer, MD +45 2015 1221 bte@croxxmed.com
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04456816
Other Study ID Numbers  ICMJE SynAct-CS003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SynAct Pharma Aps
Study Sponsor  ICMJE SynAct Pharma Aps
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Henrik Birn, Professor Aarhus Universitetshospital
PRS Account SynAct Pharma Aps
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP