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Kidney DiseasesPhase 2NCT04123613

Multiple Doses of DM199 in Patients With Chronic Kidney Disease (REDUX)

A Phase 2 study testing DM199 in people with Kidney Diseases, run by DiaMedica Therapeutics Inc at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An open-label, Phase II, multi-center study evaluating multiple doses of DM199 in participants with chronic kidney disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Diseases
What is being tested?
DM199
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
14 sitesUnited States
Study dates
17 Dec 2019to 16 Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Research by Design LLC

    Chicago, Illinois, 60643

  • Innovative Healthcare Institute

    Coral Springs, Florida, 33067

  • Nephrotex Research Group, LLC

    Dallas, Texas, 75231

  • RDRI

    DeSoto, Texas, 75115

  • Elixia at Florida Kidney Physicians-SE

    Fort Lauderdale, Florida, 33308

  • Amcis Research Center

    Granada Hills, California, 91334

  • Pines Clinical Research-Hollywood

    Hollywood, Florida, 33024

  • IMD Clinical Trials Inc

    Los Angeles, California, 90033

  • Boise Kidney & Hypertension Institute

    Meridian, Idaho, 83642

  • Aventiv Research

    Mesa, Arizona, 85210

  • New Orleans Center for Clinical Research, an AMR Company

    New Orleans, Louisiana, 70119

  • Amicis Reserch Center

    Northridge, California, 91324

  • Elixia at Florida Kidney Physicians

    Temple Terrace, Florida, 33637

  • Elixia At Clincal Renal Associates

    Upland, Pennsylvania, 19013

Other trials in United States

About this study

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

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

Read the 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

Conditions
Kidney Diseases
Being tested
DM199
Medical subject headings
Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DM199Drug

    A pharmaceutical formulation comprised of recombinant human tissue kallikrein-1 (rhKLK-1) that is being developed as an injectable protein drug

Study groups in NCT04123613
Study groupRoleWhat they receive
2.0 µg/kg, multiple doseExperimentaln=45 with 15 Participants from cohort 1, 15 from cohort 2, and 15 from cohort 3
Receives: Drug: DM199
5.0 µg/kg, multiple doseExperimentaln=45 with 15 Participants from cohort 1, 15 from cohort 2 and 15 from cohort 3
Receives: Drug: DM199

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment emergent adverse events

    Incidence, severity, and causality of adverse events

    Measured: 12 weeks

  2. Change in renal function

    eGFR

    Measured: 12 weeks

  3. Change in urine albumin to creatinine ratio

    UACR change from baseline

    Measured: 12 weeks

  4. Plasma measurements of DM199

    Maximum plasma concentration of DM199

    Measured: 12 weeks

Secondary outcomes (7)

  1. Tumor necrosis factor receptor 1 (TNF R1) concentration in plasma, change from baseline

    TNF R1 change from baseline

    Measured: 12 weeks

  2. C-reactive protein (CRP) concentration in plasma, change from baseline

    CRP change from baseline

    Measured: 12 weeks

  3. Matrix metalloproteainase-9 (MMP-9) concentration in plasma, change from baseline

    MMP-9 change from baseline

    Measured: 12 weeks

  4. Vascular endothelial growth factor (VEGF) concentration in plasma, change from baseline

    VEGF change from baseline

    Measured: 12 weeks

  5. Cystatin C concentration in plasma, change from baseline

    Cystatin C change from baseline

    Measured: 12 weeks

  6. Prostaglandin E2 concentration in plasma, change from baseline

    Prostaglandin E2 change from baseline

    Measured: 12 weeks

  7. Prostacyclin concentration in plasma, change from baseline

    Prostacyclin change from baseline

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2019
  2. Study start17 Dec 2019
  3. Primary completion16 Mar 2022
  4. Study completion16 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04123613
Sponsor's protocol ID
DM199-2019-001
Status last verified
Mar 2022
First submitted
8 Oct 2019
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DM199 in people with Kidney Diseases, run by DiaMedica Therapeutics Inc at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment emergent adverse events (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04123613.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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