This study will be evaluating the safety and efficacy of propagermanium for the treatment of participants with DKD 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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
Immediate release capsule
Placebo capsule
Renal Research
Gosford, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Boxhill Hospital
Box Hill, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Sunshine Hospital
Melbourne, Victoria, Australia
Melbourne Renal Research Group
Melbourne, Victoria, Australia
...and 3 more locations
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.
Time frame: Twelve weeks
The Effect of Treatment with Propagermanium Compared to Placebo on Measures of Estimated Glomerular Filtration Rate
Assessed by measuring estimated glomerular filtration rate.
Time frame: Twelve weeks
The Number of Adverse Events with the Adjunct use of Propagermanium
Adverse events will be recorded by a patient diary and by site staff during site visits.
Time frame: 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.
Time frame: Eleven 24-hour urine samples at week -2, week -1, week 6, week 11, week 12.
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