| Trial ID: | L1095 |
| Source ID: | NCT04126538
|
| Associated Drug: |
Pirfenidone Capsule
|
| Title: |
Pirfenidone Capsule in Patients With Chronic Kidney Disease G2 and G3a Study on Safety and Pharmacokinetics
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Insufficiency
|
| Interventions: |
DRUG: pirfenidone capsule|DRUG: pirfenidone capsule
|
| Outcome Measures: |
Primary: Plasma drug concentrations of pirfenidone, up to 24 weeks|Urine concentration of pirfenidone, up to 24 weeks | Secondary: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, up to 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Beijing Continent Pharmaceutical Co, Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2019-08-27
|
| Completion Date: |
2022-06-30
|
| Results First Posted: |
|
| Last Update Posted: |
2022-03-29
|
| Locations: |
Wuhan Union Hospital, Wuhan, Hubei, 430022, China
|
| URL: |
https://clinicaltrials.gov/show/NCT04126538
|
