| Trial ID: | L0499 |
| Source ID: | NCT03795389
|
| Associated Drug: |
Dm199
|
| Title: |
Study to Assess PK, Safety and Tolerability in Patients With DM and CKD
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Chronic Kidney Disease, Stage 3 (Moderate)|Chronic Kidney Disease, Stage 4 (Severe)|Diabetes
|
| Interventions: |
DRUG: DM199
|
| Outcome Measures: |
Primary: Safety as assessed by incidence, severity, and causality of adverse events, 11 days|Tolerability as assessed by incidence and severity of AEs, 11 days|plasma measurements of DM199, as measured in the three different dosing groups; 3.0 ug/kg, 5.0 ug/kg, and 8.0 ug/kg., 11 days|DM199 urine concentrations of KLK1, urine KLK1 will be measured pre and post study drug administration., 11 days | Secondary: C Reactive protein (CRP), 11 days|Matrix Metalloproteinase-9 (MMP-9), 11 days|Vascular Endothelial Growth Factor (VEGF), 11 days|Nitric Oxide (NO), 11 days|Serum creatinine, 11 days|Cystatin C, 11 days|neutrophil gelatinase-associated prostaglandin E2, 11 days|Urine Kidney Injury Molecule-1 (Kim1), 11 days | Other: serum creatinine, 11 days|Blood glucose, 11 days
|
| Sponsor/Collaborators: |
Sponsor: DiaMedica Therapeutics Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
33
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-02-12
|
| Completion Date: |
2019-07-21
|
| Results First Posted: |
|
| Last Update Posted: |
2021-09-13
|
| Locations: |
Clinical Pharmacology of Miami, Hialeah, Florida, 33014, United States|Orlando Clinical Research Center Inc, Orlando, Florida, 32803, United States|Prism Research, Saint Paul, Minnesota, 55114, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03795389
|
