Chronic Kidney Diseases

Contact a Trial Coordinator for more information on our trials.

Trial Summary

Recruiting

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

Condition

Kidney Diseases

Actual Start Date

December 17, 2019

Estimated Primary Completion Date

December 2021

About the Trial

Multiple Dose Levels of DM199 in Patients with Chronic Kidney Disease

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.

Detailed Info

Brief Summary

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

Phase 2

Study Type

Interventional

Estimated Enrollment

90

Interventions

Drug: DM199

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

December 2021

Sponsor

DiaMedica Therapeutics Inc

Eligibility

Gender

Male & Female

Age

18 years and older

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
  • 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
  • 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

Location

The following cities have DM199 clinical trial sites. Please check back often as locations will be updated.

Mesa, Arizona

Recruiting

United States

Granada Hills, California

Recruiting

United States

Los Angeles, California

Recruiting

United States

Northridge, California

Recruiting

United States

Coral Springs, Florida

Recruiting

United States

Fort Lauderdale, Florida

Recruiting

United States

Hollywood, Florida

Recruiting

United States

Temple Terrace, Florida

Recruiting

United States

Meridian, Idaho

Recruiting

United States

Chicago, Illinois

Recruiting

United States

New Orleans, Louisiana

Recruiting

United States

Upland, Pennsylvania

Recruiting

United States

Dallas, Texas

Recruiting

United States

DeSoto, Texas

Recruiting

United States

Enrollment

For more information on enrollment into our current clinical trial, please contact us or visit clinicaltrials.gov for location information.

Frequently Asked Questions

A Clinical Trial is a research study in which people volunteer to help find answers to specific health questions. When carefully conducted, they are the safest and fastest way to find new treatments and ways to improve health.

REDUX is being conducted for many reasons:

  • to determine whether DM199 is safe and effective for people to use.
  • to study different two dose levels of DM199 to determine if there are differences in safety and/or efficacy related to dose level.
  • to study the effects of DM199 on three separate causes of chronic kidney disease.

This clinical trial has certain criteria that a person has to meet to determine if they can participate. The Eligibility criteria are listed above and contain both inclusion and exclusion requirements. After you have discussed the trial with your doctor, contact DiaMedica to coordinate with the study site closest to where you live.

DiaMedica Therapeutics Inc. is sponsoring this clinical trial.

There will be a total of approximately 90 patients enrolled in this clinical trial.

Have your physician complete the contact form.

The safety and efficacy of the investigational use of this product has not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.