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Trial record 2 of 4 for:    DiaMedica

A Study to Asses Pharmacokinetics, Safety, and Tolerability of DM199 in Patients With Diabetes Mellitus and Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03795389
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
DiaMedica Therapeutics Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Chronic Kidney Disease, Stage 3 (Moderate) Chronic Kidney Disease, Stage 4 (Severe) Diabetes Drug: DM199 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Open-label Investigation to Assess the Pharmacokinetics, Safety and Tolerability of DM199 in Patients With Diabetes Mellitus and Chronic Kidney Disease
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: 3.0 µg/kg SC, single dose
n=8, study group of T1D or T2D with stage 3 CKD. separate n=8 of study group with T1D or T2D with CKD stage 4).
Drug: DM199
Single SC dose

Experimental: 5.0 µg/kg SC, single dose
n=8, study group of T1D or T2D with stage 3 CKD.
Drug: DM199
Single SC dose

Experimental: 8.0 µg/kg SC, single dose
n=8, study group of T1D or T2D with stage 3 CKD.
Drug: DM199
Single SC dose




Primary Outcome Measures :
  1. Safety as assessed by incidence, severity, and causality of adverse events [ Time Frame: 11 days ]
  2. Tolerability as assessed by incidence and severity of AEs [ Time Frame: 11 days ]
  3. plasma measurements of DM199 [ Time Frame: 11 days ]
    as measured in the three different dosing groups; 3.0 ug/kg, 5.0 ug/kg, and 8.0 ug/kg.

  4. DM199 urine concentrations of KLK1 [ Time Frame: 11 days ]
    urine KLK1 will be measured pre and post study drug administration.


Secondary Outcome Measures :
  1. C Reactive protein (CRP) [ Time Frame: 11 days ]
  2. Matrix Metalloproteinase-9 (MMP-9) [ Time Frame: 11 days ]
  3. Vascular Endothelial Growth Factor (VEGF) [ Time Frame: 11 days ]
  4. Nitric Oxide (NO) [ Time Frame: 11 days ]
  5. Serum creatinine [ Time Frame: 11 days ]
  6. Cystatin C [ Time Frame: 11 days ]
  7. neutrophil gelatinase-associated prostaglandin E2 [ Time Frame: 11 days ]
  8. Urine Kidney Injury Molecule-1 (Kim1) [ Time Frame: 11 days ]

Other Outcome Measures:
  1. serum creatinine [ Time Frame: 11 days ]
  2. Blood glucose [ Time Frame: 11 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is willing and able to provide informed consent for study participation.
  • Subject is ≥ 18 years of age.
  • Subject has an established diagnosis of T1D or T2D as determined by medical evaluation at screen.
  • Subjects A1c <9.8%
  • Subject is clinically stable with respect to underlying renal impairment and diabetes, as assessed by the Investigator's medical evaluation.
  • Subject has been diagnosed with Stage 3 CKD as defined by eGFR (MDRD) between 30 - <60 or Stage 4 as defined by eGFR <30 (not on dialysis) at screening.
  • Subject has a body mass index (BMI) between 18 to 45 kg/m2 (inclusive).

Exclusion Criteria:

  • Subject has positive drug test for drugs of abuse and/or positive alcohol breath test at screening and Day 0.
  • Subject is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
  • Subject has a history of significant allergic diathesis such as urticaria, angioedema, or anaphylaxis.
  • Subject has had any live vaccination ≤ 3 months prior to enrollment or will require vaccination during the study.
  • Subject must not be taking an ACEi medication for 5 half-lives prior to study drug administration and for 5 days post study drug administration.
  • Subject is unwilling or unable to limit smoking to ≤ 10 cigarettes per day (or other products that contain nicotine limited to < 200 mg of nicotine/day) during the study participation period.
  • Subject has a current malignancy or active malignancy ≤ 3 years prior to enrollment except basal cell or squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy and ≥ six months have elapsed since the procedure.
  • Subject has an active infection at the time of enrollment, and/or a history of clinically significant acute bacterial, viral, or fungal systemic infections that required systemic treatment in the last four weeks prior to enrollment.
  • Subject has known medical history of alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency).
  • Subject has serological evidence of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (Anti-HCV) at screen.
  • Subject is pregnant or nursing or is planning a pregnancy during the study period.
  • Subject is male or female of childbearing potential, is participating in sexual activity that could lead to pregnancy and is unable or unwilling to practice medically effective contraception during the study.
  • Subject has received any investigational drug or device within 14 days (or 5 half lives, whichever is longer) prior to study drug administration on Day 1
  • Subject has renal artery stenosis as determine at screen with medical history.
  • Subject has hypotension as defined by systolic blood pressure ≤ 90 and diastolic blood pressure ≤ 60 mmHg.
  • Subject has Proteinuria: PCR>2000mg/gm (spot testing).
  • Subject does not have adequate venous access for blood sampling.
  • Subject has any other medical condition which, in the opinion of the Investigator, will make participation medically unsafe or interfere with the study results.
  • Subject has any other clinically significant abnormalities in laboratory test results at screening that would, in the opinion of the Investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data.
  • Subject has any of the following conditions as determined by ECG or medical record:

    • Any significant arrhythmia or conduction abnormality, which, in the opinion of the Investigators and Medical Monitor, may interfere with the safety of the subject.
  • Subject is taking Cimetidine, St. John's Wort, or any other herbal or probiotic supplement.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795389


Contacts
Contact: Hannah Verdoorn, BA 7634965361 hverdoorn@diamedica.com
Contact: Jennifer Johnson 7632601597 jjohnson@diamedica.com

Locations
United States, Florida
Clinical Pharmacology of Miami Recruiting
Hialeah, Florida, United States, 33014
Contact: Yeny Ramos         
Principal Investigator: Maria Bermudez, MD         
Orlando Clinical Research Center Inc Recruiting
Orlando, Florida, United States, 32803
Contact: Hannah Mason         
Principal Investigator: Thomas Marbury, MD         
United States, Minnesota
Prism Research Recruiting
Saint Paul, Minnesota, United States, 55114
Contact: Jennifer Bookey         
Principal Investigator: George Canas, MD         
Sponsors and Collaborators
DiaMedica Therapeutics Inc

Responsible Party: DiaMedica Therapeutics Inc
ClinicalTrials.gov Identifier: NCT03795389     History of Changes
Other Study ID Numbers: DM199-2018-001
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by DiaMedica Therapeutics Inc:
Diabetes
Chronic Kidney Disease

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Diseases
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency