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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 May 2022 |
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Main ID: |
NCT03373786 |
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Date of registration:
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22/10/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of RG-012 in Subjects With Alport Syndrome
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Scientific title:
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A Phase 1, Open-Label Study to Evaluate the Safety, Pharmacodynamics, and Pharmacokinetics of RG-012 for Injection, Including Its Effect on Renal microRNA-21, in Subjects With Alport Syndrome |
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Date of first enrolment:
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December 22, 2017 |
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Target sample size:
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4 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03373786 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Clinical Sciences & Operations, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Males or females, ages 18 to 65 years
2. Confirmed diagnosis of Alport syndrome
3. eGFR between 40 and 90 mL/min/1.73m2
4. Proteinuria of at least 300 mg protein/g creatinine
5. For subjects taking an ACE inhibitor or an ARB, the dosing regimen should be stable
for at least 30 days prior to screening
6. Willing to comply with contraception requirements
Exclusion Criteria:
1. Causes of chronic kidney disease aside from Alport syndrome (such as diabetic
nephropathy, hypertensive nephropathy, lupus nephritis, or IgA nephropathy)
2. End stage renal disease (ESRD) as evidenced by ongoing dialysis therapy or history of
renal transportation
3. Any other condition that may pose a risk to the subject's safety and well-being
4. Female subjects who are pregnant or lactating
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alport Syndrome
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Intervention(s)
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Drug: RG012
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Primary Outcome(s)
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Effect of RG-012 on renal microRNA-21 (miR-21)
[Time Frame: 8 weeks]
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Safety - Adverse Events
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Pharmacokinetic (PK) parameter - AUC
[Time Frame: 8 weeks]
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Pharmacokinetic (PK) parameter - Cmax
[Time Frame: 8 weeks]
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Pharmacokinetic (PK) parameter - Tmax
[Time Frame: 8 weeks]
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Secondary ID(s)
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PDY16327
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RG012-06
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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