- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04456816
A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria
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
Study Overview
Status
Conditions
Intervention / 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) and severe proteinuria 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 12 weeks (28 days) as an add-on to any ongoing treatment, including ACE inhibitors/ angiotensin II receptor blocker
- Group B (6 subjects): placebo for 12 weeks (28 days) as an add-on to any ongoing treatment including ACE inhibitors/ angiotensin II receptor blocker.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Irene Sandholdt
- Phone Number: +45 2015 7033
- Email: isa@croxxmed.com
Study Contact Backup
- Name: Birgitte Telmer, MD
- Phone Number: +45 2015 1221
- Email: bte@croxxmed.com
Study Locations
-
-
-
Aarhus, Denmark, 8200
- Recruiting
- Aarhus Universitetshospital
-
Contact:
- Henrik Birn, Professor
- Phone Number: +45 40460271
- Email: henrbirn@rm.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 100 mg AP1189
100 mg AP1189.
The treatment is a 12-weeks treatment.
Each daily dose will be administered as a tablet
|
100 mg AP1189 tablet
|
Experimental: Placebo
Placebo.
The treatment is a 12-weeks treatment.
Each daily dose will be administered as a tablet
|
Matching placebo tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Event
Time Frame: Week 12
|
Evaluation of Adverse Event
|
Week 12
|
Serious Adverse Events
Time Frame: Week 12
|
Evaluation of Serious Adverse Events
|
Week 12
|
ALAT change in plasma samples
Time Frame: Week 12
|
Evaluation of ALAT compared with baseline
|
Week 12
|
ASAT change in plasma samples
Time Frame: Week 12
|
Evaluation of ASAT compared with baseline
|
Week 12
|
Total bilirubin change in plasma samples
Time Frame: Week 12
|
Evaluation of total bilirubin compared with baseline
|
Week 12
|
Alkaline phosphatase change in plasma samples
Time Frame: Week 12
|
Evaluation of alkaline phosphatase compared with baseline
|
Week 12
|
Protein change in 24 hours urinary protein excretion
Time Frame: Week 12
|
Change of protein in urine excretion compared to baseline measured in 24 h urinary protein excretion
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Albumin change in 24 hours urinary protein excretion
Time Frame: Week 12
|
Change of albumin in urine excretion compared to baseline measured in 24 h urinary protein excretion
|
Week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Henrik Birn, Professor, Aarhus Universitetshospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Urologic Diseases
- Urological Manifestations
- Urination Disorders
- Nephritis
- Glomerulonephritis
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Proteinuria
- Nephrotic Syndrome
- Nephrosis
- Glomerulonephritis, Membranous
Other Study ID Numbers
- SynAct-CS003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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