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Trial record 3 of 6 for:    dm199

Multiple Doses of DM199 in Patients With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT04123613
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
DiaMedica Therapeutics Inc

Tracking Information
First Submitted Date  ICMJE October 8, 2019
First Posted Date  ICMJE October 11, 2019
Last Update Posted Date August 20, 2021
Actual Study Start Date  ICMJE December 17, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
  • Incidence of treatment emergent adverse events [ Time Frame: 12 weeks ]
    Incidence, severity, and causality of adverse events
  • Change in renal function [ Time Frame: 12 weeks ]
    eGFR
  • Change in urine albumin to creatinine ratio [ Time Frame: 12 weeks ]
    UACR change from baseline
  • Plasma measurements of DM199 [ Time Frame: 12 weeks ]
    Maximum plasma concentration of DM199
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
  • Tumor necrosis factor receptor 1 (TNF R1) concentration in plasma, change from baseline [ Time Frame: 12 weeks ]
    TNF R1 change from baseline
  • C-reactive protein (CRP) concentration in plasma, change from baseline [ Time Frame: 12 weeks ]
    CRP change from baseline
  • Matrix metalloproteainase-9 (MMP-9) concentration in plasma, change from baseline [ Time Frame: 12 weeks ]
    MMP-9 change from baseline
  • Vascular endothelial growth factor (VEGF) concentration in plasma, change from baseline [ Time Frame: 12 weeks ]
    VEGF change from baseline
  • Cystatin C concentration in plasma, change from baseline [ Time Frame: 12 weeks ]
    Cystatin C change from baseline
  • Prostaglandin E2 concentration in plasma, change from baseline [ Time Frame: 12 weeks ]
    Prostaglandin E2 change from baseline
  • Prostacyclin concentration in plasma, change from baseline [ Time Frame: 12 weeks ]
    Prostacyclin change from baseline
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
  • Tumor necrosis factor receptor 1 (TNF R1) [ Time Frame: 12 weeks ]
    TNF R1 change from baseline
  • C-reactive protein (CRP) [ Time Frame: 12 weeks ]
    CRP change from baseline
  • Matrix metalloproteainase-9 (MMP-9) [ Time Frame: 12 weeks ]
    MMP-9 change from baseline
  • Vascular endothelial growth factor (VEGF) [ Time Frame: 12 weeks ]
    VEGF change from baseline
  • Cystatin C [ Time Frame: 12 weeks ]
    Cystatin C change from baseline
  • Prostaglandin E2 [ Time Frame: 12 weeks ]
    Prostaglandin E2 change from baseline
  • Prostacyclin [ Time Frame: 12 weeks ]
    Prostacyclin change from baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiple Doses of DM199 in Patients With Chronic Kidney Disease
Official Title  ICMJE A Multi-Center Open-label Investigation to Assess the Safety and Efficacy of Multiple Doses of DM199 in Patients With Chronic Kidney Disease
Brief Summary An open-label, Phase II, multi-center study evaluating multiple doses of DM199 in participants with chronic kidney disease.
Detailed Description

This is an open-label, Phase II, multi-center study evaluating DM199 in approximately 90 Participants in three cohorts.

Cohort I: African Americans with CKD (Stage II or III), hypertension and non-diabetic Cohort II: Participants with IgA nephropathy diagnosis and CKD (Stage II or III) Cohort III: Diabetes Mellitus (Type II) with CKD (Stage II or III) and hypertension

Participants in each cohort will be enrolled in a parallel assignment to one of two doses:

Dose 1: DM199 2.0 µg/kg SC 2x week for 95 days Dose 2: DM199 5.0 µg/kg SC 2x week for 95 days

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Diseases
Intervention  ICMJE Drug: DM199
A pharmaceutical formulation comprised of recombinant human tissue kallikrein-1 (rhKLK-1) that is being developed as an injectable protein drug
Study Arms  ICMJE
  • Experimental: 2.0 µg/kg, multiple dose
    n=45 with 15 Participants from cohort 1, 15 from cohort 2, and 15 from cohort 3
    Intervention: Drug: DM199
  • Experimental: 5.0 µg/kg, multiple dose
    n=45 with 15 Participants from cohort 1, 15 from cohort 2 and 15 from cohort 3
    Intervention: Drug: DM199
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2020)
90
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2019)
60
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Cohort I

  • African American
  • Hypertension as defined by the American Heart Association for Stage I hypertension where systolic blood pressure (BP) ≥130 mmHg or diastolic BP ≥ 80 mmHg or on medication for treatment of hypertension.

Cohort II

  • IgA nephropathy confirmed by medical history with biopsy

Cohort III

  • Diabetes Mellitus (Type 2) with hypertension where systolic blood pressure (BP) ≥130 mmHg or diastolic BP ≥ 80 mmHg or on medication for treatment of hypertension
  • Hemoglobin A1c ≥7% at screening

Both Cohorts

  • Participant is willing and able to provide informed consent for study participation
  • Participant male or female ≥ 18 years of age
  • Participant has CKD as defined by using CKD EPI for Stage II 60 to <90 mL/min/1.73 m2 or Stage III 30 to <60 mL/min/1.73 m2
  • UACR >150 mg/g and <5000 mg/g at screening
  • Participant is clinically stable with respect to underlying renal impairment as assessed by the Investigator's medical evaluation

Exclusion Criteria:

  • Participant has positive drug test for drugs of abuse and/or positive alcohol breath test at screening and Day 1
  • Participant has a current diagnosis and/or is taking medication or diet control for diabetes (cohort I and II only)
  • Participant has an A1c > 7% at screening (cohort I and II only)
  • Participant received corticosteroid therapy within last 3 months
  • Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits
  • Participant has a history of significant allergic diathesis such as urticaria, angioedema, or anaphylaxis
  • Participant has been previously diagnosed with kidney disease other than for hypertension, IgA or Diabetes Mellitus (Type II)
  • Participant has hypotension as defined by systolic blood pressure ≤ 90 mmHg and diastolic blood pressure ≤ 60 mmHg at screen
  • ACEi or GLP-1 medication prescribed for and taken by Participant (must not be taking for 5 half-lives prior to study drug administration and for 10 days post study drug administration)
  • Participant has a current malignancy or active malignancy ≤ 2 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 ≥ 6 months have elapsed since the procedure
  • Participant 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 with a completed therapy in the last 7 days prior to enrollment
  • Participant has known medical history of alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency)
  • Participant is pregnant or nursing or is planning a pregnancy during the study period
  • Participant 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
  • Participant has received any investigational drug or device within 14 days (or 5 half lives, whichever is longer) prior to study drug administration starting on Day 1
  • Participant has renal artery stenosis as determined at screen with medical history
  • Participant received a kidney transplant
  • Participant does not have adequate venous access for blood sampling
  • Participant has any other medical condition which, in the opinion of the Investigator, will make participation medically unsafe or interfere with the study results
  • Participant has any other clinically significant abnormalities in laboratory test results at screening that would, in the opinion of the Investigator, increase the Participant's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data
  • Participant has any significant arrhythmia or conduction abnormality, which in the opinion of the Investigators and Medical Monitor may interfere with the safety of the Participant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sydney A Gilman, PHD 240.644.8353 sgilman@diamedica.com
Contact: Beth Larson-DeBruzzi, PharmD 763.496.5192 blarson@diamedica.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04123613
Other Study ID Numbers  ICMJE DM199-2019-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party DiaMedica Therapeutics Inc
Study Sponsor  ICMJE DiaMedica Therapeutics Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Harry Alcorn, Pharm.D. DiaMedica Inc.
PRS Account DiaMedica Therapeutics Inc
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP