Safety and Effectiveness of Propagermanium in Focal Segmental Glomerulosclerosis Participants Rec… (NCT03649152) | Clinical Trial Compass
CompletedPhase 2
Safety and Effectiveness of Propagermanium in Focal Segmental Glomerulosclerosis Participants Receiving Irbesartan
Australia8 participantsStarted 2018-11-08
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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;
What they're measuring
1
The Number of Adverse Events with the Adjunct use of Propagermanium Compared to Placebo in Participants with FSGS who are Receiving Irbesartan
✓. 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;
Exclusion criteria
✕. 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);
✕. 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;