Chronic Kidney DiseasePhase 1NCT03795389
Study to Assess PK, Safety and Tolerability in Patients With DM and CKD
A Phase 1 study testing DM199 in people with Chronic Kidney Disease and Chronic Kidney Disease, Stage 3 (Moderate), run by DiaMedica Therapeutics Inc at 3 sites in United States.
Trial summary
An open-label, phase IB, multi-center study evaluating DM199 in subjects with Type 1 Diabetes or Type 2 Diabetes and Stage 3 or 4 Chronic Kidney Disease. The primary objectives of this study are to evaluate safety, tolerability, and PK profile of DM199 in these subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Chronic Kidney Disease, Stage 3 (Moderate), Chronic Kidney Disease, Stage 4 (Severe)
- What is being tested?
- DM199
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Feb 2019to 21 Jul 2019
- Phase
- Phase 1
- 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
- Subject is willing and able to provide informed consent for study participation.
- Subject is ≥ 18 years of age.
- Subject has an established diagnosis of T1D or T2D as determined by medical evaluation at screen.
- Subjects A1c <9.8%
- Subject is clinically stable with respect to underlying renal impairment and diabetes, as assessed by the Investigator's medical evaluation.
- Subject has been diagnosed with Stage 3 CKD as defined by eGFR (MDRD) between 30 - <60 or Stage 4 as defined by eGFR <30 (not on dialysis) at screening.
- Subject has a body mass index (BMI) between 18 to 45 kg/m2 (inclusive).
Who cannot join
- Subject has positive drug test for drugs of abuse and/or positive alcohol breath test at screening and Day 0.
- Subject is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
- Subject has a history of significant allergic diathesis such as urticaria, angioedema, or anaphylaxis.
- Subject has had any live vaccination ≤ 3 months prior to enrollment or will require vaccination during the study.
- Subject must not be taking an ACEi medication for 5 half-lives prior to study drug administration and for 5 days post study drug administration.
- Subject is unwilling or unable to limit smoking to ≤ 10 cigarettes per day (or other products that contain nicotine limited to < 200 mg of nicotine/day) during the study participation period.
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- Subject has a current malignancy or active malignancy ≤ 3 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 ≥ six months have elapsed since the procedure.
- Subject 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 in the last four weeks prior to enrollment.
- Subject has known medical history of alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency).
- Subject has serological evidence of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (Anti-HCV) at screen.
- Subject is pregnant or nursing or is planning a pregnancy during the study period.
- Subject 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.
- Subject has received any investigational drug or device within 14 days (or 5 half lives, whichever is longer) prior to study drug administration on Day 1
- Subject has renal artery stenosis as determine at screen with medical history.
- Subject has hypotension as defined by systolic blood pressure ≤ 90 and diastolic blood pressure ≤ 60 mmHg.
- Subject has Proteinuria: PCR>2000mg/gm (spot testing).
- Subject does not have adequate venous access for blood sampling.
- Subject has any other medical condition which, in the opinion of the Investigator, will make participation medically unsafe or interfere with the study results.
- Subject has any other clinically significant abnormalities in laboratory test results at screening that would, in the opinion of the Investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data.
- Subject has any of the following conditions as determined by ECG or medical record:
- Any significant arrhythmia or conduction abnormality, which, in the opinion of the Investigators and Medical Monitor, may interfere with the safety of the subject.
- Subject is taking Cimetidine, St. John's Wort, or any other herbal or probiotic supplement.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Pharmacology of Miami
Hialeah, Florida, 33014
Orlando Clinical Research Center Inc
Orlando, Florida, 32803
Prism Research
Saint Paul, Minnesota, 55114
About this study
Official title: A Multi-Center Open-label Investigation to Assess the Pharmacokinetics, Safety and Tolerability of DM199 in Patients With Diabetes Mellitus and Chronic Kidney Disease
An open-label, phase IB, multi-center study evaluating DM199 in subjects with Type 1 Diabetes or Type 2 Diabetes and Stage 3 or 4 Chronic Kidney Disease. The primary objectives of this study are to evaluate safety, tolerability, and PK profile of DM199 in these subjects.
Read the detailed description
The study evaluates the safety, tolerability, and PK profile of DM199 in subjects with T1D or T2D and with Stage 3 or Stage 4 CKD. Additionally, this study evaluates urine concentrations of KLK1 pre and post dose.
Cohort 1: Subjects with T1D or T2D and Stage 3 CKD will be administered one of three DM199 doses: 3.0 ug/kg or 5.0 ug/kg or 8.0 ug/kg single SC dose. Cohort 2: Subjects with T1D or T2D and Stage 4 CKD will be administered a single 3.0 µg/kg single SC dose. Secondary and exploratory study objectives include collection and analysis of vital signs, biomarkers, eGFR, blood glucose, and ECG's.
- Conditions
- Chronic Kidney Disease, Chronic Kidney Disease, Stage 3 (Moderate), Chronic Kidney Disease, Stage 4 (Severe), Diabetes
- Being tested
- DM199
- Keywords
- Diabetes, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic, Lymphoma, Follicular, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM199Drug
Single SC dose
| Study group | Role | What they receive |
|---|---|---|
| 3.0 µg/kg SC, single dose | Experimental | n=8, study group of T1D or T2D with stage 3 CKD. separate n=8 of study group with T1D or T2D with CKD stage 4). Receives: Drug: DM199 |
| 5.0 µg/kg SC, single dose | Experimental | n=8, study group of T1D or T2D with stage 3 CKD. Receives: Drug: DM199 |
| 8.0 µg/kg SC, single dose | Experimental | n=8, study group of T1D or T2D with stage 3 CKD. Receives: Drug: DM199 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by incidence, severity, and causality of adverse events
Measured: 11 days
Tolerability as assessed by incidence and severity of AEs
Measured: 11 days
plasma measurements of DM199
as measured in the three different dosing groups; 3.0 ug/kg, 5.0 ug/kg, and 8.0 ug/kg.
Measured: 11 days
DM199 urine concentrations of KLK1
urine KLK1 will be measured pre and post study drug administration.
Measured: 11 days
Secondary outcomes (8)
C Reactive protein (CRP)
Measured: 11 days
Matrix Metalloproteinase-9 (MMP-9)
Measured: 11 days
Vascular Endothelial Growth Factor (VEGF)
Measured: 11 days
Nitric Oxide (NO)
Measured: 11 days
Serum creatinine
Measured: 11 days
Cystatin C
Measured: 11 days
neutrophil gelatinase-associated prostaglandin E2
Measured: 11 days
Urine Kidney Injury Molecule-1 (Kim1)
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start12 Feb 2019
- Primary completion21 Jul 2019
- Study completion21 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- DiaMedica Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harry Alcorn, Pharm.D., Study director, DiaMedica Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795389
- Sponsor's protocol ID
- DM199-2018-001
- Status last verified
- Jul 2019
- First submitted
- 3 Jan 2019
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Open-label Investigation to Assess the Pharmacokinetics, Safety and Tolerability of DM199 in Patients With Diabetes Mellitus and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03795389
- Acronym / sponsor ID
- DM199-2018-001
- Conditions
- Chronic Kidney Disease, Chronic Kidney Disease, Stage 3 (Moderate), Chronic Kidney Disease, Stage 4 (Severe), Diabetes
- Keywords
- Diabetes, Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- DiaMedica Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 21 Jul 2019 (actual)
- Study completion
- 21 Jul 2019 (actual)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, phase IB, multi-center study evaluating DM199 in subjects with Type 1 Diabetes or Type 2 Diabetes and Stage 3 or 4 Chronic Kidney Disease. The primary objectives of this study are to evaluate safety, tolerability, and PK profile of DM199 in these subjects.
Detailed description
The study evaluates the safety, tolerability, and PK profile of DM199 in subjects with T1D or T2D and with Stage 3 or Stage 4 CKD. Additionally, this study evaluates urine concentrations of KLK1 pre and post dose.
Cohort 1: Subjects with T1D or T2D and Stage 3 CKD will be administered one of three DM199 doses: 3.0 ug/kg or 5.0 ug/kg or 8.0 ug/kg single SC dose. Cohort 2: Subjects with T1D or T2D and Stage 4 CKD will be administered a single 3.0 µg/kg single SC dose. Secondary and exploratory study objectives include collection and analysis of vital signs, biomarkers, eGFR, blood glucose, and ECG's.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3.0 µg/kg SC, single dose | Experimental | Drug: DM199n=8, study group of T1D or T2D with stage 3 CKD. separate n=8 of study group with T1D or T2D with CKD stage 4). |
| 5.0 µg/kg SC, single dose | Experimental | Drug: DM199n=8, study group of T1D or T2D with stage 3 CKD. |
| 8.0 µg/kg SC, single dose | Experimental | Drug: DM199n=8, study group of T1D or T2D with stage 3 CKD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is willing and able to provide informed consent for study participation.
- Subject is ≥ 18 years of age.
- Subject has an established diagnosis of T1D or T2D as determined by medical evaluation at screen.
- Subjects A1c <9.8%
- Subject is clinically stable with respect to underlying renal impairment and diabetes, as assessed by the Investigator's medical evaluation.
Key exclusion criteria (22 listed)
- Subject has positive drug test for drugs of abuse and/or positive alcohol breath test at screening and Day 0.
- Subject is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
- Subject has a history of significant allergic diathesis such as urticaria, angioedema, or anaphylaxis.
- Subject has had any live vaccination ≤ 3 months prior to enrollment or will require vaccination during the study.
- Subject must not be taking an ACEi medication for 5 half-lives prior to study drug administration and for 5 days post study drug administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DM199Single SC dose | Drug | 3.0 µg/kg SC, single dose, 5.0 µg/kg SC, single dose, 8.0 µg/kg SC, single dose |
Primary outcome
Safety as assessed by incidence, severity, and causality of adverse events
Time frame: 11 days
Tolerability as assessed by incidence and severity of AEs
Time frame: 11 days
plasma measurements of DM199
Time frame: 11 days
as measured in the three different dosing groups; 3.0 ug/kg, 5.0 ug/kg, and 8.0 ug/kg.
DM199 urine concentrations of KLK1
Time frame: 11 days
urine KLK1 will be measured pre and post study drug administration.
8 secondary outcomes
C Reactive protein (CRP)
Time frame: 11 days
Matrix Metalloproteinase-9 (MMP-9)
Time frame: 11 days
Vascular Endothelial Growth Factor (VEGF)
Time frame: 11 days
Nitric Oxide (NO)
Time frame: 11 days
Serum creatinine
Time frame: 11 days
Cystatin C
Time frame: 11 days
neutrophil gelatinase-associated prostaglandin E2
Time frame: 11 days
Urine Kidney Injury Molecule-1 (Kim1)
Time frame: 11 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Alcorn, Pharm.D. study director
DiaMedica Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DM199 in people with Chronic Kidney Disease and Chronic Kidney Disease, Stage 3 (Moderate), run by DiaMedica Therapeutics Inc at 3 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 7 inclusion and 22 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 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety as assessed by incidence, severity, and causality of adverse events (time frame: 11 days). 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?
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 13 Sep 2021.