A double-blind study for patients with idiopathic membranous nephropathy in treatment with ACE inhibor or angiotensin II receptor blockers. The trial will take place in hospitals in Europe. To better assess the mechanism of action of AP1189, the compound is compared to an inactive substance (placebo).The purpose of the trial is to investigate the safety of the new drug, its tolerability, uptake, metabolism, distribution, and excretion in the body (pharmacokinetics) and its effect

Phase 1

• Conditions: Idiopathic membranous nephropathy; MedDRA version: 21.1Level: LLTClassification code 10027170Term: Membranous nephropathySystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 21.1Level: PTClassification code 10029164Term: Nephrotic syndromeSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-000971-18-NO
• Lead Sponsor: SynAct Pharma ApS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-23
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1.Written informed consent has been obtained prior to initiating any study-specific procedures
2.Male and female subjects, 18 to 85 years of age with a renal biopsy consistent with iMN
3.Diagnosed as anti-PLA2-Receptor positive by local laboratory
4.Nephrotic syndrome defined by a U-protein/creatinine ratio >3.5 g/g and/or U-albumin/creatinine ratio >2.2 g/g and P-albumin below the lower normal limit
5.eGFR > 30 ml/min/1.73m2
6.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 effects
7.Females of child-bearing potential using reliable means of contraception (for detailed information see section 22.8) or are post-menopausal (menstrual periods stopped at least 12 months ahead of the enrolment in the trial) or are surgically sterilized (the procedure must have been performed at least 6 months prior to screening)
8.Females of childbearing potential with negative pregnancy test at screening and baseline

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

1.Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry
2.Major surgery within 8 weeks prior to screening or planned surgery within one month following randomization
3.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”
4.Treated with systemic (oral, intramuscular or IV) corticosteroids, or other immune suppressive, or immune modulating compounds within 4 weeks (8 weeks for IV cyclophosphamide) prior to screening (and during the entire treatment period and until the final visit)
5.Treated with rituximab within 12 months of screening
6.Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured).
7.Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
8.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal disease
9.Pregnant women or nursing (breastfeeding) mothers
10.History of alcohol, drug, or chemical abuse within the 6 months prior to screening
11.Any condition that in the view of the investigator would suggest that the patient is unable to comply with study protocol and procedures (e.g., psychiatric disorders, dementia)
12. Any history of sensitivity to the IMP ingredients sucralose, starch, tartrazine, and microcrystalline cellulose

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified