CompletedPhase 2ACTRN12614001132639

A phase II study for treatment of proteinuria in patients currently on irbesartan therapy

An open label, Phase II dose escalation and expansion study to evaluate the safety and efficacy of propagermanium (PPG) added to stable angiotensin receptor blocker therapy (irbesartan) for the treatment of patients with proteinuria

Sponsor

Dimerix Bioscience Pty Ltd

Enrollment

30 participants

Start Date

Sep 3, 2015

Study Type

Interventional

Conditions

Proteinuria

Summary

The study is to investigate the safety and tolerability of propagermanium on patients exhibiting proteinuria and who are already taking standard irbesartan therapy.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria10

Capable of providing informed consent.
Women of child bearing potential or men of reproductive potential must be using adequate birth control measures.
Previously diagnosed with protein in the urine and have a protein/creatinine ratio (PCR) of greater than 50 (mg/mmol) based on 24 hour urine collection.
Patients with a defined level of kidney function as follows:
serum creatinine 115 to 291 micromol/L inclusive for women
serum creatinine 132 to 309 micromol/L inclusive for men
or estimated GFR 20-60
Taking stable irbesartan with BP in range of 110/70 to 150/95 mmHg. (Stable is defined as taking the same dose of IRB for at least 90 days prior to baseline).
Liver function tests less than or equal to 2X upper limit of normal
Patients taking a diuretic must be on a stable dose for at least 2 months.

Exclusion Criteria11

Rapidly progressing proteinuria (rapidly progressing is defined as a trebling of proteinuria over the preceding 3 month period)
Recent gastrointestinal bleeding
Heart disease that is not considered stable
Acute kidney injury within the 3 months before screening
Are receiving any ACE inhibitor, NSAID therapy or spironolactone
Have uncontrolled blood pressure
Required to take drugs that change the immune system (immunosupressants)
HIV infection
Viral Hepatitis B or C, liver infection, liver cirrhosis or any clinically significant liver damage. (Liver function tests > 2X ULN)
Cancer within 3 years (excluding non melanoma skin cancer) or high risk of developing cancer
Major surgery within 3 months of screening or planned during the study period.

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Interventions

The intervention is propagermanium (PPG), which is an oral capsule taken three times daily. Participants must be taking stable irbesartan. This is a dose escalation study, in which each patient re

The intervention is propagermanium (PPG), which is an oral capsule taken three times daily. Participants must be taking stable irbesartan. This is a dose escalation study, in which each patient receives increasing doses of PPG every 4 weeks (30mg, 60mg, 90mg, 150mg, 240mg per day) until normalisation of proteinuria. Once proteinuria is within the normal range the current dose becomes that patients final dose, and the patient will remain on their final dose for up to a further 8 weeks. The exposure period ranges from 84 days (if proteinuria is normalised at 30mg) though to 168 days (if a patient is escalated through all doses to the maximal dose). Additionally, there is a screening period ranging from 14 to 42 days and a follow-up period of 28 days where the participant is not exposed to propagermanium.