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Safety and Effectiveness of Propagermanium in Focal Segmental Glomerulosclerosis 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: NCT03649152
Recruitment Status : Active, not recruiting
First Posted : August 28, 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 FSGS 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 16 weeks, followed by a six week washout period followed by Treatment Period 2 taking a placebo capsule twice a day for 16 weeks.

OR Treatment Period 1 taking a placebo capsule twice a day for 16 weeks, followed by a six week washout period followed by Treatment Period 2 taking a propagermanium capsule twice a day for 16 weeks.


Condition or disease Intervention/treatment Phase
Focal Segmental Glomerulosclerosis Drug: Propagermanium Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 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 2a, Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving Irbesartan
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Propagermanium then Placebo

Propagermanium one capsule orally twice daily for 16 weeks. Compliance will be measured by drug accountability and completion of a participant diary.

Participants will receive 16 weeks propagermanium and 16 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 16 weeks. Compliance will be measured by drug accountability and completion of a participant diary.

Participants will receive 16 weeks placebo and 16 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 Number of Adverse Events with the Adjunct use of Propagermanium Compared to Placebo in Participants with FSGS who are Receiving Irbesartan [ Time Frame: Sixteen weeks ]
    Assessed by monitoring of adverse events


Secondary Outcome Measures :
  1. The Frequency of Proteinuria-Based Responses to Treatment Compared to Placebo [ Time Frame: Sixteen weeks ]
    Assessed by testing a 24-hour urine sample.



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 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18 to 80 (inclusive) at screening;
  2. A diagnosis of primary FSGS confirmed by renal biopsy;
  3. Must be receiving a stable dose of 300 mg daily dose 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;
  4. Patients can be on stable doses of angiotensin converting enzyme inhibitors, aldosterone inhibitors, direct renin inhibitor 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.
  5. If taking immunosuppressive medications (except for rituximab or cyclophosphamide), must have a stable treatment regime for 3 months prior to screening and do not have plans to alter the regimen except to maintain therapeutic immunosuppression or in the event of adverse events. Patients who have received rituximab or cyclophosphamide must have ceased treatment for at least 6 months prior to screening;
  6. Mean of two protein/creatinine ratio values (screening and baseline) of ≥ 1326 mg/g (150 mg/mmol), and within ± 30% of the screening value at the baseline assessment;
  7. Estimated glomerular filtration rate ≥ 25 mL/min/1.73 m^2 using chronic kidney disease epidemiology collaboration (CKD-EPI) formula at screening;
  8. Serum potassium levels (screening and baseline) < 5.5 mmol/L. If either value is 5.5 or above, the patient may receive dietary advice and be retested 1 week later;
  9. 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;
  10. 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;
  11. Have given written informed consent prior to any study procedures being performed.

Exclusion Criteria:

  1. Has FSGS secondary to another condition;
  2. A history of type 1 diabetes mellitus, diagnosis of type 2 diabetes mellitus prior to FSGS positive renal biopsy, or non-fasting blood glucose > 180 mg/dL (10 mmol/L) at screening;
  3. A prior kidney organ or stem cell transplant;
  4. A major adverse cardiac event within 6 months before screening;
  5. 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;
  6. Jaundice, active hepatitis, or known hepatobiliary disease (except asymptomatic cholelithiasis);
  7. Alanine aminotransferase and/or aspartate aminotransferase more than two times the upper limit of normal at screening;
  8. 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;
  9. Positive screening assessment for viral hepatitis B surface antigen or hepatitis C virus (HCV) antibody AND positive HCV RNA or human immunodeficiency virus (HIV), or a history of illicit drug injecting;
  10. Seated blood pressure of ≥ 160/100 mmHg at screening;
  11. Body mass index ≥ 35 kg/m^2 at screening;
  12. Past hospitalisation for a major depressive episode;
  13. Is breast feeding or pregnant;
  14. Unable to comply with the study procedures and assessments, including the ability swallow capsules;
  15. 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;
  16. 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): NCT03649152


Locations
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Australia, New South Wales
Renal Research
Gosford, New South Wales, Australia, 2250
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Westmead
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
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Austion Hospital
Heidelberg, Victoria, Australia, 3084
Sunshine Hospital
Melbourne, Victoria, Australia, 3021
Melbourne Renal Research Group
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: NCT03649152    
Other Study ID Numbers: DMX-200-202 A
ACTRN12618000910202p ( Registry Identifier: Australia New Zealand Clinical Trials Registry )
First Posted: August 28, 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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Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Proxigermanium
Irbesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs