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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12618000982213p | 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 DKD 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propagermanium then Placebo | Experimental | 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. |
|
| Placebo then Propagermanium | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propagermanium | Drug | Immediate release capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Albumin/Creatinine Ratio with Adjunct use of Propagermanium Compared to Placebo in Participants with DKD who are Receiving Irbesartan | Assessed by measuring albumin/creatinine ratio. | Twelve weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Effect of Treatment with Propagermanium Compared to Placebo on Measures of Estimated Glomerular Filtration Rate | Assessed by measuring estimated glomerular filtration rate. | Twelve weeks |
| The Number of Adverse Events with the Adjunct use of Propagermanium |
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Inclusion Criteria:
Aged 18 to 90 (inclusive) at screening;
A diagnosis of type 2 diabetes mellitus;
Baseline glycated haemoglobin (HbA1c) ≤ 12%;
Fasting plasma glucose < 21 mmol/L;
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;
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;
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;
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;
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
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 | Australia | |||
| Liverpool Hospital |
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Double-blind, Randomised, Placebo-Controlled, Crossover Study
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| Placebo | Drug | Placebo capsule |
|
Adverse events will be recorded by a patient diary and by site staff during site visits. |
| Twelve weeks |
| The Effect of Treatment with Propagermanium on Measures of Proteinuria as measured by ACR | Assessed by measuring albumin/creatinine ratio at each end point. | Eleven 24-hour urine samples at week -2, week -1, week 6, week 11, week 12. |
| Liverpool |
| New South Wales |
| 2170 |
| Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Sunshine Coast University Hospital | Birtinya | Queensland | 4575 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Boxhill Hospital | Box Hill | Victoria | 3128 | Australia |
| Austin Hospital | Heidelberg | Victoria | 3084 | Australia |
| Sunshine Hospital | Melbourne | Victoria | 3021 | Australia |
| Melbourne Renal Research Group | Melbourne | Victoria | Australia |
| Royal Melbourne Hospital | Melbourne | Victoria | Australia |
| St Vincents Hospital | Melbourne | Victoria | Australia |
| Epworth Hospital | Richmond | Victoria | 3121 | Australia |
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C066750 | propagermanium |
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