Focal Segmental GlomerulosclerosisPhase 2ACTIONNCT03649152
Safety and Effectiveness of Propagermanium in Focal Segmental Glomerulosclerosis Participants Receiving Irbesartan
A Phase 2 study testing Propagermanium in people with Focal Segmental Glomerulosclerosis, run by Dimerix Bioscience Pty Ltd at 11 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Focal Segmental Glomerulosclerosis
- What is being tested?
- Propagermanium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 11 sitesAustralia
- Study dates
- 8 Nov 2018to 13 Jul 2020
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 (inclusive) at screening;
- A diagnosis of primary FSGS confirmed by renal biopsy;
- 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;
- 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.
- 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;
- 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;
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- Estimated glomerular filtration rate ≥ 25 mL/min/1.73 m^2 using chronic kidney disease epidemiology collaboration (CKD-EPI) formula at screening;
- 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;
- 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;
- 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;
- Have given written informed consent prior to any study procedures being performed.
Who cannot join
- Has FSGS secondary to another condition;
- 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;
- A prior kidney organ or stem cell transplant;
- A major adverse cardiac event within 6 months before screening;
- 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;
- Jaundice, active hepatitis, or known hepatobiliary disease (except asymptomatic cholelithiasis);
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- Alanine aminotransferase and/or aspartate aminotransferase more than two times the upper limit of normal at screening;
- 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;
- 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;
- Seated blood pressure of ≥ 160/100 mmHg at screening;
- Body mass index ≥ 35 kg/m^2 at screening;
- Past hospitalisation for a major depressive episode;
- Is breast feeding or pregnant;
- Unable to comply with the study procedures and assessments, including the ability swallow capsules;
- 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;
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Australia11 sites
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Box Hill Hospital
Box Hill, Victoria, 3128
Renal Research
Gosford, New South Wales, 2250
Austion Hospital
Heidelberg, Victoria, 3084
Liverpool Hospital
Liverpool, New South Wales, 2170
Sunshine Hospital
Melbourne, Victoria, 3021
Melbourne Renal Research Group
Melbourne, Victoria
Epworth Hospital
Richmond, Victoria, 3121
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Westmead
Westmead, New South Wales, 2145
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
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
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.
Read more
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.
- Conditions
- Focal Segmental Glomerulosclerosis
- Being tested
- Propagermanium, Placebo
- Medical subject headings
- Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropagermaniumDrug
Also called PPG, repagermanium, DMX-200
Immediate release capsule
PlaceboDrug
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Propagermanium then Placebo | Experimental | 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. Receives: Drug: Propagermanium; Drug: Placebo |
| Placebo then Propagermanium | Experimental | 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. Receives: Drug: Propagermanium; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Adverse Events with the Adjunct use of Propagermanium Compared to Placebo in Participants with FSGS who are Receiving Irbesartan
Assessed by monitoring of adverse events
Measured: Sixteen weeks
Secondary outcomes (1)
The Frequency of Proteinuria-Based Responses to Treatment Compared to Placebo
Assessed by testing a 24-hour urine sample.
Measured: Sixteen weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start8 Nov 2018
- Primary completion16 Jun 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focal Segmental GlomerulosclerosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, Randomised, Placebo-Controlled, Crossover Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dimerix Bioscience Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Simon Roger, MD, Principal investigator, Renal Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649152
- Sponsor's protocol ID
- DMX-200-202 A
- Other IDs
- ACTRN12618000910202p
- Acronym
- ACTION
- Status last verified
- Feb 2020
- First submitted
- 7 Aug 2018
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
PubMed 35224732
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03649152
- Acronym / sponsor ID
- ACTION / DMX-200-202 A
- Conditions
- Focal Segmental Glomerulosclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dimerix Bioscience Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 28 Aug 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, Randomised, Placebo-Controlled, Crossover Study
| Arm | Type | Receives |
|---|---|---|
| Propagermanium then Placebo | Experimental | Drug: Propagermanium, Drug: PlaceboPropagermanium 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. |
| Placebo then Propagermanium | Experimental | Drug: Propagermanium, Drug: PlaceboPropagermanium 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Aged 18 to 80 (inclusive) at screening;
- A diagnosis of primary FSGS confirmed by renal biopsy;
- 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;
- 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.
- 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;
Key exclusion criteria (16 listed)
- Has FSGS secondary to another condition;
- 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;
- A prior kidney organ or stem cell transplant;
- A major adverse cardiac event within 6 months before screening;
- 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;
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 |
|---|---|---|
| PropagermaniumAlso: PPG, repagermanium, DMX-200Immediate release capsule | Drug | Placebo then Propagermanium, Propagermanium then Placebo |
| PlaceboPlacebo capsule | Drug | Placebo then Propagermanium, Propagermanium then Placebo |
Primary outcome
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
1 secondary outcome
The Frequency of Proteinuria-Based Responses to Treatment Compared to Placebo
Time frame: Sixteen weeks
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 29 Jul 2022.
- Derived from this study: PubMed 35224732Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
- Individual participant dataSharing planned: Undecided
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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.
Simon Roger, MD principal investigator
Renal Research
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propagermanium in people with Focal Segmental Glomerulosclerosis, run by Dimerix Bioscience Pty Ltd at 11 sites in Australia.
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 13 inclusion and 16 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 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03649152, which also lists 1 linked publication.
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 29 Jul 2022.