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Multiple Doses of DM199 in Patients With Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04123613
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
DiaMedica Therapeutics Inc

Brief Summary:
An open-label, Phase II, multi-center study evaluating multiple doses of DM199 in participants with chronic kidney disease.

Condition or disease Intervention/treatment Phase
Kidney Diseases Drug: DM199 Phase 2

Detailed Description:

This is an open-label, Phase II, multi-center study evaluating DM199 in approximately 60 (sixty) Participants in two 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)

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 Safety and Efficacy of Multiple Doses of DM199 in Patients With Chronic Kidney Disease
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: 2.0 µg/kg, multiple dose
n=30 with 15 Participants from cohort 1 and 15 from cohort 2
Drug: DM199
A pharmaceutical formulation comprised of recombinant human tissue kallikrein-1 (rhKLK-1) that is being developed as an injectable protein drug

Experimental: 5.0 µg/kg, multiple dose
n=30 with 15 Participants from cohort 1 and 15 from cohort 2
Drug: DM199
A pharmaceutical formulation comprised of recombinant human tissue kallikrein-1 (rhKLK-1) that is being developed as an injectable protein drug




Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events [ Time Frame: 12 weeks ]
    Incidence, severity, and causality of adverse events

  2. Change in renal function [ Time Frame: 12 weeks ]
    eGFR

  3. Change in urine albumin to creatinine ratio [ Time Frame: 12 weeks ]
    UACR change from baseline

  4. Plasma measurements of DM199 [ Time Frame: 12 weeks ]
    Maximum plasma concentration of DM199


Secondary Outcome Measures :
  1. Tumor necrosis factor receptor 1 (TNF R1) concentration in plasma, change from baseline [ Time Frame: 12 weeks ]
    TNF R1 change from baseline

  2. C-reactive protein (CRP) concentration in plasma, change from baseline [ Time Frame: 12 weeks ]
    CRP change from baseline

  3. Matrix metalloproteainase-9 (MMP-9) concentration in plasma, change from baseline [ Time Frame: 12 weeks ]
    MMP-9 change from baseline

  4. Vascular endothelial growth factor (VEGF) concentration in plasma, change from baseline [ Time Frame: 12 weeks ]
    VEGF change from baseline

  5. Cystatin C concentration in plasma, change from baseline [ Time Frame: 12 weeks ]
    Cystatin C change from baseline

  6. Prostaglandin E2 concentration in plasma, change from baseline [ Time Frame: 12 weeks ]
    Prostaglandin E2 change from baseline

  7. Prostacyclin concentration in plasma, change from baseline [ Time Frame: 12 weeks ]
    Prostacyclin change from baseline



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:

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 mmHg1 or on medication for treatment of hypertension.

Cohort II

  • IgA nephropathy confirmed by medical history with biopsy

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
  • Participant has an A1c > 7% at screening
  • 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 or IgA
  • Participant has hypotension as defined by systolic blood pressure ≤ 90 mmHg and diastolic blood pressure ≤ 60 mmHg at screen
  • ACEi 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

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): NCT04123613


Contacts
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Contact: Jennifer Johnson 763-260-1597 jjohnson@diamedica.com

Locations
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United States, Arizona
Aventiv Research Recruiting
Mesa, Arizona, United States, 85210
Contact: Exodus Edmerson         
Principal Investigator: Kenneth Boren, MD         
United States, Florida
Elixia at Florida Kidney Physicians-SE Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Amy Santiago         
Principal Investigator: Zachary Yablon, MD         
Pines Clinical Research-Hollywood Recruiting
Hollywood, Florida, United States, 33024
Contact: Jennifer Varon         
Principal Investigator: Steven Zeig, MD         
Elixia at Florida Kidney Physicians Recruiting
Temple Terrace, Florida, United States, 33637
Contact: Renee Edwards         
Principal Investigator: Pablo Ruiz-Ramon, MD         
United States, Georgia
IACT Health Recruiting
Columbus, Georgia, United States, 31904
Contact: James Cutts         
Principal Investigator: Arachelvi Dhandayuthapani, MD         
United States, Texas
RDRI Not yet recruiting
DeSoto, Texas, United States, 75115
Contact: Zena Cooper         
Principal Investigator: Venkata Yalamanchili, MD         
Sponsors and Collaborators
DiaMedica Therapeutics Inc

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Responsible Party: DiaMedica Therapeutics Inc
ClinicalTrials.gov Identifier: NCT04123613     History of Changes
Other Study ID Numbers: DM199-2019-001
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency