| Trial ID: | L0395 |
| Source ID: | NCT04913272
|
| Associated Drug: |
Us-Apr2020
|
| Title: |
Clinical Trial To Evaluate Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With Chronic Kidney Disease Stage IV
|
| Acronym: |
CKD
|
| Status: |
SUSPENDED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease stage4
|
| Interventions: |
DRUG: US-APR2020|DRUG: Placebo
|
| Outcome Measures: |
Primary: Evaluate incidences of Treatment-Emergent Adverse Events following KT-301 (formerly US-APR2020) administration in patients with Chronic Kidney disease (CKD) Stage IV as a measure of safety., Presence of adverse events in less than 10% of the study population, as a measure of safety, six months|Evaluate the change of eGFR as per NKF-USFDA guidelines following KT-301 (formerly US-APR2020) administration in patients with Chronic Kidney disease (CKD) Stage IV as a measure of clinical efficacy., Arresting the change of Estimated glomerular filtration rate (eGFR) as per National Kidney Foundation- US Food and Drug Administration (NKF-USFDA )guidelines in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo, as a measure of efficacy., six months | Secondary: Evaluate changes in basic blood uremic metabolic markers, Change in any of the basic blood uremic metabolic markers in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo: * Blood Urea Nitrogen (BUN) * Uric acid * Serum creatinine * Urea/creatinine ratio * Micro albumin urea, six months|Evaluate changes in complete blood count and hematology parameters, Change in any of the complete blood count (CBC) and hematology parameters in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo: * Red blood cells * White blood cells * Platelets * Hemoglobin (Hgb) * Hematocrit (Hct) Ferritin, six months|Evaluate changes in C-Reactive Protein (CRP) levels, Change in C-Reactive Protein (CRP) levels in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo, six months|Evaluate change in quality of life (QOL)- SF36 QOL questionnaire, six months
|
| Sponsor/Collaborators: |
Sponsor: Kibow Pharma
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
630
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-06-24
|
| Completion Date: |
2025-12
|
| 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/NCT04913272
|
