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

NCT04456816 | Recruiting Phase 2

• 1 other identifier: SynAct-CS003
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy; Severe Proteinuria Due to Idiopathic Membranous Nephropathy

Outcome Measures

Primary Outcomes (7)

• Adverse Event

  Evaluation of Adverse Event

  Week 12

• Serious Adverse Events

  Evaluation of Serious Adverse Events

  Week 12

• ALAT change in plasma samples

  Evaluation of ALAT compared with baseline

  Week 12

• ASAT change in plasma samples

  Evaluation of ASAT compared with baseline

  Week 12

• Total bilirubin change in plasma samples

  Evaluation of total bilirubin compared with baseline

  Week 12

• Alkaline phosphatase change in plasma samples

  Evaluation of alkaline phosphatase compared with baseline

  Week 12

• Protein change in 24 hours urinary protein excretion

  Change of protein in urine excretion compared to baseline measured in 24 h urinary protein excretion

  Week 12

Secondary Outcomes (1)

• Albumin change in 24 hours urinary protein excretion

  Week 12

Study Arms (2)

100 mg AP1189

EXPERIMENTAL

100 mg AP1189. The treatment is a 12-weeks treatment. Each daily dose will be administered as a tablet

Drug: 100 mg AP1189

Placebo

EXPERIMENTAL

Placebo. The treatment is a 12-weeks treatment. Each daily dose will be administered as a tablet

Drug: Placebo

Interventions

Placebo DRUG

Matching placebo tablet

Placebo

100 mg AP1189 DRUG

100 mg AP1189 tablet

100 mg AP1189

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent has been obtained prior to initiating any study-specific procedures
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SynAct Pharma Aps: lead

Study Sites (1)

Aarhus Universitetshospital

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Interventions

N-(3-(1-(2-nitrophenyl)-1H-pyrrol-2-yl)allylidenamino)guanidine

Study Officials

• Henrik Birn, Professor

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Sandholdt

CONTACT

+45 2015 7033; isa@croxxmed.com

Birgitte Telmer, MD

CONTACT

+45 2015 1221; bte@croxxmed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Exploratory, randomized, double-blind, multi-center, placebo-controlled 12-weeks study with repeated doses of AP1189

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 7, 2020
• Study Start: August 31, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

DK (1)