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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12618000910202p | Registry Identifier | Australia New Zealand Clinical Trials Registry |
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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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This study will be evaluating the safety and efficacy of propagermanium for the treatment of participants with FSGS who are already taking irbesartan by:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propagermanium | Drug | Immediate release capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Sixteen weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Frequency of Proteinuria-Based Responses to Treatment Compared to Placebo | Assessed by testing a 24-hour urine sample. | Sixteen weeks |
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Inclusion Criteria:
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;
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:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Roger, MD | Renal Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renal Research | Gosford | New South Wales | 2250 | Australia | ||
| Liverpool Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35224732 | Derived | 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. |
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Double-blind, Randomised, Placebo-Controlled, Crossover Study
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| Placebo | Drug | Placebo capsule |
|
| Liverpool |
| New South Wales |
| 2170 |
| Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Westmead | Westmead | New South Wales | 2145 | Australia |
| Sunshine Coast University Hospital | Birtinya | Queensland | 4575 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Austion Hospital | Heidelberg | Victoria | 3084 | Australia |
| Sunshine Hospital | Melbourne | Victoria | 3021 | Australia |
| Melbourne Renal Research Group | Melbourne | Victoria | Australia |
| Epworth Hospital | Richmond | Victoria | 3121 | Australia |
| ID | Term |
|---|---|
| D005923 | Glomerulosclerosis, Focal Segmental |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C066750 | propagermanium |
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