| Trial ID: | L0508 |
| Source ID: | NCT05407389
|
| Associated Drug: |
Kt-301 (Formerly Us-Apr2020)
|
| Title: |
Rollover Extension Clinical Trial To Evaluate The Long-Term Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With CKD IV Completing The US-APR2020-01 Study
|
| Acronym: |
|
| Status: |
SUSPENDED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease stage4
|
| Interventions: |
DRUG: KT-301 (formerly US-APR2020)
|
| Outcome Measures: |
Primary: Evaluate the long-term safety of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV, Presence of adverse events in less than 10% of the study population, as a measure of safety Chronic Kidney Disease (CKD) Stage IV, 6 months|Evaluate the clinical efficacy of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV, Arresting the decline of eGFR as per NKF-USFDA guidelines following date of roll- over transition until study competition, compared to baseline (End of study for US- APR2020-01) as a measure of clinical efficacy, 6 months | Secondary: Evaluate changes in basic blood uremic metabolic markers, 6 months|Evaluate changes in complete blood count and hematology parameters, 6 months|Reduction in C-Reactive Protein (CRP) levels following date of roll-over transition until study competition, 6 months|Percent change in rating scale (Modified SF36 QOL questionnaire) from roll-over transition until study competition (at 24-weeks), 6 months
|
| Sponsor/Collaborators: |
Sponsor: Kibow Pharma
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
600
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-04-21
|
| Completion Date: |
2026-03
|
| Results First Posted: |
|
| Last Update Posted: |
2024-09-19
|
| Locations: |
Jadedstone Clinical Research, Silver Spring, Maryland, 20904, United States|Kidney Michigan, Saginaw, Michigan, 48604, United States|South Carolina Clinical Research, Orangeburg, South Carolina, 29118, United States|Almeda Medical Clinic, Houston, Texas, 77058, United States|Mendez Center for Clinical Research, Woodbridge, Virginia, 22192, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05407389
|
