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NCT03795389
Study to Assess PK, Safety and Tolerability in Patients With DM and CKD
Phase 1 trial testing DM199 in Chronic Kidney Disease in 33 participants. Completed in 21 July 2019.
21 July 2019
Quick facts
| Lead sponsor | DiaMedica Therapeutics Inc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 12 February 2019 |
| Primary completion | 21 July 2019 |
| Estimated completion | 21 July 2019 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- DM199 — full drug profile →
Conditions studied
- Chronic Kidney Disease — all drugs for Chronic Kidney Disease →
- Chronic Kidney Disease, Stage 3 (Moderate) — all drugs for Chronic Kidney Disease, Stage 3 (Moderate) →
- Chronic Kidney Disease, Stage 4 (Severe) — all drugs for Chronic Kidney Disease, Stage 4 (Severe) →
- Diabetes — all drugs for Diabetes →
Sponsor
DiaMedica Therapeutics Inc — full company profile →
Who can join
18 and older, any sex, with Chronic Kidney Disease or Chronic Kidney Disease, Stage 3 (Moderate). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
An open-label, phase IB, multi-center study evaluating DM199 in subjects with Type 1 Diabetes or Type 2 Diabetes and Stage 3 or 4 Chronic Kidney Disease. The primary objectives of this study are to evaluate safety, tolerability, and PK profile of DM199 in these subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03795389
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of DM199
Trials testing the same drug.
- NCT04123613 — Multiple Doses of DM199 in Patients With Chronic Kidney Disease (REDUX) · Phase 2 · completed
Other recruiting trials for Chronic Kidney Disease
Currently open trials in the same condition.
- NCT07469540 — Effects of an Aerobic Exercise Program on Cardiovascular Risk in Patients With Chronic Kidney Disease or Rheumatoid Arth · NA · recruiting
- NCT07169422 — Improving Kidney Care in Type 2 Diabetes: A Study of Pharmacist Prescribing Versus Usual Care · NA · recruiting
- NCT07481526 — A Prospecitve Multicenter, Observational Registry Study · recruiting
- NCT07450820 — OPTIMISE-CKD Study_Dapagliflozin Effectiveness in CKD · recruiting
- NCT07107945 — A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease · Phase 3 · recruiting
Other DiaMedica Therapeutics Inc trials
Trials by the same sponsor.
- NCT04123613 — Multiple Doses of DM199 in Patients With Chronic Kidney Disease (REDUX) · Phase 2 · completed
- NCT03290560 — Evaluation to Assess Safety and Tolerability of DM199 in Subjects With Acute Ischemic Stroke · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03795389 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by DiaMedica Therapeutics Inc
- Last refreshed: 13 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03795389.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing