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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04736628




Registration number
NCT04736628
Ethics application status
Date submitted
1/02/2021
Date registered
3/02/2021

Titles & IDs
Public title
A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease
Scientific title
Randomised, Double-blind (Within Dose Groups), Placebo Controlled and Parallel Group Trial to Investigate the Effects of Different Doses of Oral BI 685509 Given Over 20 Weeks on UACR Reduction in Patients With Non-diabetic Kidney Disease
Secondary ID [1] 0 0
2020-002930-33
Secondary ID [2] 0 0
1366-0022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Avenciguat
Treatment: Drugs - Placebo

Experimental: Dose group 1: Avenciguat - Low dose.

Placebo comparator: Dose group 1: Matching placebo - Matching placebo for low dose.

Experimental: Dose group 2: Avenciguat - Low dose followed by up-titration to medium dose.

Placebo comparator: Dose group 2: Matching placebo - Matching placebo for low dose followed by up-titration to medium dose.

Experimental: Dose group 3: Avenciguat - Low dose followed by up-titration to medium dose, followed by up-titration to high-dose.

Placebo comparator: Dose group 3: Matching placebo - Matching placebo for low dose followed by up-titration to medium dose, followed by up-titration to high dose.


Treatment: Drugs: Avenciguat
Avenciguat

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in 10-hour urine after 20 weeks of trial treatment.
Timepoint [1] 0 0
Up to 20 weeks
Secondary outcome [1] 0 0
Change from baseline in log transformed UACR measured in First Morning Void urine after 20 weeks of trial treatment.
Timepoint [1] 0 0
Up to 20 weeks
Secondary outcome [2] 0 0
Proportion of patients achieving UACR decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment.
Timepoint [2] 0 0
Up to 20 weeks
Secondary outcome [3] 0 0
Proportion of patients achieving UACR decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment.
Timepoint [3] 0 0
Up to 20 weeks

Eligibility
Key inclusion criteria
* Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
* Male or female patients aged =18 years at time of consent.
* Estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) = 20 and < 90 mL/min/1.73 m2 at Visit 1 by central laboratory analysis. eGFR must remain =20 mL/min/1.73 m2 after Visit 1 up to the start of Visit 3, measured by central or any local laboratory analysis.
* Urine albumin creatinine ratio (UACR) = 200 and < 3,500 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit 1.
* Patients with macroalbuminuria (>300 mg/g) should be treated with the highest tolerated dose of either Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both). For patients with microalbuminuria the use of ACEi or ARB is at the discretion of the Investigator. Treatment should be at a stable dose for = 4 weeks before Visit 1 with no planned change of the therapy during the trial.
* If the patient is taking any of the following medications they should be on a stable dose at least 4 weeks prior to visit 1 until start of treatment, with no planned change of the therapy during the trial: anti-hypertensives, non-steroidal anti-inflammatory drugs (NSAIDs), endothelin receptor antagonists, systemic steroids or Sodium-glucose co-transporter-2 (SGLT2) inhibitors.
* In the Investigator's judgment any kind of diagnosed chronic kidney disease whose primary cause is clinically not considered to be of diabetic origin.

Further inclusion criteria apply
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Treatment with Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either ACEi or ARB), Phosphodiesterase-5-inhibitors, non-specific phosphodiesterase inhibitors (such as dipyridamole and theophylline), Nitric Oxide (NO) donors including nitrates, soluble Guanylate Cyclase (sGC)-stimulators/activators (other than trial treatment) or any other restricted medication (including Organic Anion-Transporting Polypeptide 1B1 and 1B3 (OATP1B1/3) inhibitors, Uridine 5'-diphosphate -glucuronosyltransferase (UGT) inhibitors/inducers) as provided in the Investigator Site File (ISF) within 4 weeks prior to visit 1 and throughout screening and baseline run-in. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
* Any clinically relevant laboratory value from screening until start of trial treatment which, in the investigator's judgement, puts the patient at additional risk.
* Diagnosed with diabetic kidney disease.
* Any immunosuppression therapy or immunotherapy in last 3 months prior to visit 1 and throughout screening and baseline run-in (except prednisolone =10 mg or equivalent).
* Acute kidney injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) definition in the 30 days prior to Visit 1 until the start of trial treatment.
* Planned start of chronic renal replacement therapy during the trial or end stage renal disease before start of trial treatment.
* Known history of moderate or severe symptomatic orthostatic dysregulation as judged by the investigator before start of trial treatment.
* The patient has an active infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (or is known to have a positive test from screening until randomisation).
* Further exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/09/2023
Sample size
Target
Accrual to date
Final
261
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Renal Research, Gosford - Gosford
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Austin Health - Heidelberg
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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Connecticut
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Delaware
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Florida
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Georgia
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Idaho
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Illinois
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Louisiana
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Nevada
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New Jersey
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North Carolina
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Tennessee
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Texas
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Argentina
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Caba
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Argentina
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Cordoba
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Argentina
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Mar del Plata
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Argentina
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Rosario
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Argentina
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Santa Fe
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Argentina
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Sarandi
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Canada
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Alberta
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Canada
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Ontario
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China
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Beijing
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China
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Chengdu
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China
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Chongqing
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China
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Xuancheng
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Denmark
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Aarhus N
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Herlev
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Holbæk
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Roskilde
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Germany
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Hannover
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Germany
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Lübeck
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Hong Kong
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Hong Kong
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Japan
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Aichi, Nagoya
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Chiba, Urayasu
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Fukuoka, Kurume
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Hyogo, Takarazuka
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Kanagawa, Kamakura
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Kyoto, Kyoto
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Mie, Kuwana
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Nagano, Matsumoto
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Okayama, Kurashiki
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Saitama, Iruma-gun
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Shizuoka, Yaizu
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Tokyo, Bunkyo-ku
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Tokyo, Chuo-ku
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Japan
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Tokyo, Itabashi-ku
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Malaysia
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Cheras, Kuala Lumpur
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Malaysia
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Ipoh, Perak
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Malaysia
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Kelantan
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Malaysia
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Kuala Lumpur
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Malaysia
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Selangor
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Mexico
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Aguascalientes
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Mexico
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Ciudad de Mexico
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Mexico
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Ciudad de México
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Mexico
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Monterrey
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Mexico
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México
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New Zealand
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Dunedin
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New Zealand
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Paraparaumu
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New Zealand
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Tauranga
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Poland
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Chrzanow
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Oswiecim
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Portugal
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Aveiro
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Portugal
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Carnaxide
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Portugal
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Lisboa
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Portugal
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Porto
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Spain
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Barcelona
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Spain
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L'Hospitalet de Llobregat
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Stockholm
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United Kingdom
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Corby
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United Kingdom
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Coventry
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United Kingdom
State/province [79] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04736628