A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN
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|ClinicalTrials.gov Identifier: NCT04456816|
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : September 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Membranous Nephropathy||Drug: 100 mg AP1189 Drug: Placebo||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|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)|
|Official Title:||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|
|Actual Study Start Date :||August 31, 2020|
|Estimated Primary Completion Date :||November 1, 2022|
|Estimated Study Completion Date :||December 31, 2022|
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.
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.
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.
Placebo powder in bottle
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456816
|Contact: Irene Sandholdt||+45 2015 email@example.com|
|Contact: Birgitte Telmer, MD||+45 2015 firstname.lastname@example.org|
|Aarhus, Denmark, 8200|
|Contact: Henrik Birn, Professor +45 40460271 email@example.com|
|Principal Investigator:||Henrik Birn, Professor||Aarhus Universitetshospital|