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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 January 2025
• Main ID: NCT04456816
• Date of registration: 24/06/2020
• Prospective Registration: Yes
• Primary sponsor: SynAct Pharma Aps
• Public title: A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria
• Scientific 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
• Date of first enrolment: August 31, 2020
• Target sample size: 23
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04456816
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Denmark

Contacts

• Name: Irene Sandholdt

• Name: Henrik Birn, Professor
• Affiliation: Aarhus Universitetshospital

• Name: Henrik Birn, Professor

Key inclusion & exclusion 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.


Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Severe Proteinuria Due to Idiopathic Membranous Nephropathy

Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy

Intervention(s)

Drug: Placebo

Drug: 100 mg AP1189

Primary Outcome(s)

Alkaline phosphatase change in plasma samples [Time Frame: Week 12]

Adverse Event [Time Frame: Week 12]

Serious Adverse Events [Time Frame: Week 12]

ASAT change in plasma samples [Time Frame: Week 12]

ALAT change in plasma samples [Time Frame: Week 12]

Protein change in 24 hours urinary protein excretion [Time Frame: Week 12]

Total bilirubin change in plasma samples [Time Frame: Week 12]

Secondary Outcome(s)

Albumin change in 24 hours urinary protein excretion [Time Frame: Week 12]

Secondary ID(s)

SynAct-CS003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors