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Safety and Effectiveness of Propagermanium in Diabetic Kidney Disease Participants Receiving Irbesartan (ACTION)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627715
Recruitment Status : Active, not recruiting
First Posted : August 13, 2018
Last Update Posted : February 6, 2020
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
Dimerix Bioscience Pty Ltd

Brief Summary:

This study will be evaluating the safety and efficacy of propagermanium for the treatment of participants with DKD who are already taking irbesartan by:

  • monitoring symptoms that participants may experience while on the study,
  • measuring levels of protein in participant's urine and kidney function during the course of the study,
  • measuring the levels of propagermanium and irbesartan that enters into participant's urine and blood, and
  • comparing the propagermanium outcomes to participants' pre-study and placebo outcomes.

Eligible participants will randomly be assigned to one of two arms to receive both the propagermanium and placebo in different orders as follows, either:

Treatment Period 1 taking a propagermanium capsule twice a day for 12 weeks, followed by a six week washout period followed by Treatment Period 2 taking a placebo capsule twice a day for 12 weeks.

OR Treatment Period 1 taking a placebo capsule twice a day for 12 weeks, followed by a six week washout period followed by Treatment Period 2 taking a propagermanium capsule twice a day for 12 weeks.


Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Drug: Propagermanium Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double-blind, Randomised, Placebo-Controlled, Crossover Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients With Diabetic Kidney Disease (DKD) Who Are Receiving Irbesartan
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Propagermanium then Placebo

Propagermanium one capsule orally twice daily for 12 weeks. Compliance will be measured by drug accountability and completion of a participant diary.

Participants will receive 12 weeks propagermanium and 12 weeks placebo separated by a 6 week washout period.

Drug: Propagermanium
Immediate release capsule
Other Names:
  • PPG
  • repagermanium
  • DMX-200

Drug: Placebo
Placebo capsule

Experimental: Placebo then Propagermanium

Propagermanium one capsule orally twice daily for 12 weeks. Compliance will be measured by drug accountability and completion of a participant diary.

Participants will receive 12 weeks placebo and 12 weeks propagermanium separated by a 6 week washout period.

Drug: Propagermanium
Immediate release capsule
Other Names:
  • PPG
  • repagermanium
  • DMX-200

Drug: Placebo
Placebo capsule




Primary Outcome Measures :
  1. The Change in Albumin/Creatinine Ratio with Adjunct use of Propagermanium Compared to Placebo in Participants with DKD who are Receiving Irbesartan [ Time Frame: Twelve weeks ]
    Assessed by measuring albumin/creatinine ratio.


Secondary Outcome Measures :
  1. The Effect of Treatment with Propagermanium Compared to Placebo on Measures of Estimated Glomerular Filtration Rate [ Time Frame: Twelve weeks ]
    Assessed by measuring estimated glomerular filtration rate.

  2. The Number of Adverse Events with the Adjunct use of Propagermanium [ Time Frame: Twelve weeks ]
    Adverse events will be recorded by a patient diary and by site staff during site visits.

  3. The Effect of Treatment with Propagermanium on Measures of Proteinuria as measured by ACR [ Time Frame: Eleven 24-hour urine samples at week -2, week -1, week 6, week 11, week 12. ]
    Assessed by measuring albumin/creatinine ratio at each end point.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18 to 90 (inclusive) at screening;
  2. A diagnosis of type 2 diabetes mellitus;
  3. Baseline glycated haemoglobin (HbA1c) ≤ 12%;
  4. Fasting plasma glucose < 21 mmol/L;
  5. Must be receiving a stable dose of 300 mg daily of irbesartan (in any marketed formulation) for at least 3 months prior to screening, and have no plan to change treatment regime throughout the study;
  6. Patients can be on stable doses of angiotensin converting enzyme inhibitors, aldosterone inhibitors, and/or sodium-glucose co-transporter-2 inhibitors. However, the dose and regimen must be stable for 3 months prior to screening and must have no plan to change treatment regime throughout the study;
  7. Mean of two albumin creatinine ratio (ACR) values (screening and baseline) of more than or equal to 265 to 4,425 mg/g (30-500 mg/mmol) and within 30% of the screening value at the baseline assessment;
  8. Estimated glomerular filtration rate more than or equal to 25-90 mL/min/1.73 m^2 using chronic kidney disease epidemiology collaboration (CKD-EPI) formula at screening;
  9. Serum potassium levels (screening and baseline) less than 5.5 mmol/L. If either value is 5.5 or above the patient may receive dietary advice and be retested one week after the second value
  10. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

    • Not of childbearing potential, defined as surgically sterile (documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or postmenopausal (no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone [FSH] level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.);
    • Of childbearing potential and agrees to use a highly effective method of contraception consistently during the treatment period and for at least 60 days after the last dose of investigational product;
  11. A male patient with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception during the treatment period and for at least 60 days after the last dose of investigational product and refrains from donating sperm during this period;
  12. Have given written informed consent prior to any study procedures being performed.

Exclusion Criteria:

  1. A history of type 1 diabetes mellitus;
  2. Current known non-diabetic renal disease. Patients with a history of other resolved renal diseases must be approved by the Sponsor;
  3. A prior organ or stem cell transplant;
  4. A major adverse cardiac event within 6 months before screening;
  5. Patients receiving immunosuppressive medications including patients receiving > 5 mg prednisone;
  6. Rapid estimated glomerular filtration rate decline with renal replacement likely during study
  7. Lymphoma, leukaemia, or any malignancy within the past 5 years except for basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ that have been resected with no evidence of metastatic disease for 3 years;
  8. Jaundice, active hepatitis, or known hepatobiliary disease (except asymptomatic cholelithiasis);
  9. Alanine aminotransferase and/or aspartate aminotransferase more than two times the upper limit of normal at screening;
  10. Participation in any clinical study with an experimental medication or device within 90 days or 5 half-lives (whichever is longer) of screening or have previously participated in a study involving propagermanium;
  11. Positive screening assessment for viral hepatitis B surface antigen or hepatitis C virus (HCV) antibody AND positive HCV ribonucleic acid or human immunodeficiency virus (HIV);
  12. Seated blood pressure of more than or equal to 160/100 mmHg at screening;
  13. Body mass index more than or equal to 42 kg/m^2 at screening;
  14. Past hospitalisation for a major depressive episode;
  15. Is breast feeding or pregnant;
  16. Unable to comply with the study procedures and assessments, including the ability swallow capsules;
  17. Any other disease, physical or psychological condition that the investigator or sponsor believes may contraindicate the use of the investigational medicinal product or affect the interpretation of study results or render the patient at high risk from treatment complications;
  18. Are investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.

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): NCT03627715


Locations
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Australia, New South Wales
Renal Research
Gosford, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Boxhill Hospital
Box Hill, Victoria, Australia, 3128
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Sunshine Hospital
Melbourne, Victoria, Australia, 3021
Melbourne Renal Research Group
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
St Vincents Hospital
Melbourne, Victoria, Australia
Epworth Hospital
Richmond, Victoria, Australia, 3121
Sponsors and Collaborators
Dimerix Bioscience Pty Ltd
Iqvia Pty Ltd
Investigators
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Principal Investigator: Simon Roger, MD Renal Research
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Responsible Party: Dimerix Bioscience Pty Ltd
ClinicalTrials.gov Identifier: NCT03627715    
Other Study ID Numbers: DMX-200-203 A
ACTRN12618000982213p ( Registry Identifier: Australia New Zealand Clinical Trials Registry )
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Proxigermanium
Antineoplastic Agents
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs