Clinical trial • Phase I • Nephrology
OJR520 for Chronic kidney disease
Phase I trial of OJR520 for Chronic kidney disease. Randomised, placebo (not specified)-controlled, adaptive. 80 participants.
Overview
- Trial Therapeutic Area
- Nephrology
- Trial Disease
- Chronic kidney disease
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 14-10-2025
- First CTIS Authorization Date
- 10-02-2026
Trial design
Randomised, placebo (not specified)-controlled, adaptive Phase I trial across 3 sites in Romania, Germany.
- Randomised
- Yes
- Comparator
- Placebo (not specified)
- Adaptive
- True, study described as "Single and Multiple Ascending Dose" (dose-escalation elements implied)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 80
Eligibility
Recruits 80 Vulnerable population not selected; no details on consent or assent provided..
- Vulnerable Population
- Vulnerable population not selected; no details on consent or assent provided.
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 13
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 44
Romania
- Earliest CTIS Part Ii Submission Date
- 24-12-2025
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 58
- Number Of Sites
- 2
- Number Of Participants
- 32
Sites
- Site Name
- Arensia Clinics S.R.L.
- Department Name
- 3001: Nephrology
- Contact Person Name
- Ioana Miler
- Contact Person Email
- ioana.miler.ext@arensia-em.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- 3002: Internal Medicine
- Contact Person Name
- Mihaela Mocan
- Contact Person Email
- mihaela.mocan.ext@arensia-em.com
Germany
- Earliest CTIS Part Ii Submission Date
- 08-01-2026
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 76
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Charite Research Organisation GmbH
- Department Name
- #2000: Pruefzentrum
- Contact Person Name
- Victoria Kegel-Huebner
- Contact Person Email
- Victoria.Kegel-Huebner@charite-research.org
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- OJR520
- Dose Escalation Increase
- Initial and subsequent doses not specified in available record
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