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

NCT04123613 | Completed Phase 2 FDA Drug

• 1 other identifier: DM199-2019-001
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Kidney Diseases

Outcome Measures

Primary Outcomes (4)

• Incidence of treatment emergent adverse events

  Incidence, severity, and causality of adverse events

  12 weeks

• Change in renal function

  eGFR

  12 weeks

• Change in urine albumin to creatinine ratio

  UACR change from baseline

  12 weeks

• Plasma measurements of DM199

  Maximum plasma concentration of DM199

  12 weeks

Secondary Outcomes (7)

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

  12 weeks

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

  12 weeks

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

  12 weeks

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

  12 weeks

• Cystatin C concentration in plasma, change from baseline

  12 weeks

Study Arms (2)

2.0 µg/kg, multiple dose

EXPERIMENTAL

n=45 with 15 Participants from cohort 1, 15 from cohort 2, and 15 from cohort 3

Drug: DM199

5.0 µg/kg, multiple dose

EXPERIMENTAL

n=45 with 15 Participants from cohort 1, 15 from cohort 2 and 15 from cohort 3

Drug: DM199

Interventions

DM199 DRUG

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

2.0 µg/kg, multiple dose; 5.0 µg/kg, multiple dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DiaMedica Therapeutics Inc: lead

Study Sites (14)

Aventiv Research

Mesa, Arizona, 85210, United States

Location

Amcis Research Center

Granada Hills, California, 91334, United States

Location

IMD Clinical Trials Inc

Los Angeles, California, 90033, United States

Location

Amicis Reserch Center

Northridge, California, 91324, United States

Location

Innovative Healthcare Institute

Coral Springs, Florida, 33067, United States

Location

Elixia at Florida Kidney Physicians-SE

Fort Lauderdale, Florida, 33308, United States

Location

Pines Clinical Research-Hollywood

Hollywood, Florida, 33024, United States

Location

Elixia at Florida Kidney Physicians

Temple Terrace, Florida, 33637, United States

Location

Boise Kidney & Hypertension Institute

Meridian, Idaho, 83642, United States

Location

Research by Design LLC

Chicago, Illinois, 60643, United States

Location

New Orleans Center for Clinical Research, an AMR Company

New Orleans, Louisiana, 70119, United States

Location

Elixia At Clincal Renal Associates

Upland, Pennsylvania, 19013, United States

Location

Nephrotex Research Group, LLC

Dallas, Texas, 75231, United States

Location

RDRI

DeSoto, Texas, 75115, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

DM199

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Harry Alcorn, Pharm.D.

  DiaMedica Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 11, 2019
• Study Start: December 17, 2019
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)