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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03649152




Registration number
NCT03649152
Ethics application status
Date submitted
7/08/2018
Date registered
28/08/2018
Date last updated
6/02/2020

Titles & IDs
Public title
Safety and Effectiveness of Propagermanium in Focal Segmental Glomerulosclerosis Participants Receiving Irbesartan
Scientific title
A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving Irbesartan
Secondary ID [1] 0 0
ACTRN12618000910202p
Secondary ID [2] 0 0
DMX-200-202 A
Universal Trial Number (UTN)
Trial acronym
ACTION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Focal Segmental Glomerulosclerosis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Propagermanium
Treatment: Drugs - Placebo

Experimental: Propagermanium then Placebo - 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.

Experimental: Placebo then Propagermanium - 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.


Treatment: Drugs: Propagermanium
Immediate release capsule

Treatment: Drugs: Placebo
Placebo capsule

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Sixteen weeks
Secondary outcome [1] 0 0
The Frequency of Proteinuria-Based Responses to Treatment Compared to Placebo - Assessed by testing a 24-hour urine sample.
Timepoint [1] 0 0
Sixteen weeks

Eligibility
Key inclusion criteria
1. Aged 18 to 80 (inclusive) at screening;

2. A diagnosis of primary FSGS confirmed by renal biopsy;

3. 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;

4. 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.

5. 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;

6. 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;

7. Estimated glomerular filtration rate = 25 mL/min/1.73 m^2 using chronic kidney disease
epidemiology collaboration (CKD-EPI) formula at screening;

8. 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;

9. A female patient is eligible to participate if she is not pregnant, not breastfeeding,
and at least 1 of the following conditions applies:

- Not of childbearing potential, defined as surgically sterile (documented
hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or
postmenopausal (no menses for 12 months without an alternative medical cause. A
high follicle stimulating hormone [FSH] level in the postmenopausal range may be
used to confirm a postmenopausal state in women not using hormonal contraception
or hormonal replacement therapy; however, in the absence of 12 months of
amenorrhea, a single FSH measurement is insufficient.);

- Of childbearing potential and agrees to use a highly effective method of
contraception consistently during the treatment period and for at least 60 days
after the last dose of investigational product;

10. 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;

11. Have given written informed consent prior to any study procedures being performed.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has FSGS secondary to another condition;

2. 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;

3. A prior kidney organ or stem cell transplant;

4. A major adverse cardiac event within 6 months before screening;

5. 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;

6. Jaundice, active hepatitis, or known hepatobiliary disease (except asymptomatic
cholelithiasis);

7. Alanine aminotransferase and/or aspartate aminotransferase more than two times the
upper limit of normal at screening;

8. 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;

9. Positive screening assessment for viral hepatitis B surface antigen or hepatitis C
virus (HCV) antibody AND positive HCV RNA or human immunodeficiency virus (HIV), or a
history of illicit drug injecting;

10. Seated blood pressure of = 160/100 mmHg at screening;

11. Body mass index = 35 kg/m^2 at screening;

12. Past hospitalisation for a major depressive episode;

13. Is breast feeding or pregnant;

14. Unable to comply with the study procedures and assessments, including the ability
swallow capsules;

15. Any other disease, physical or psychological condition that the investigator or
sponsor believes may contraindicate the use of the investigational medicinal product
or affect the interpretation of study results or render the patient at high risk from
treatment complications;

16. Are investigator site personnel directly affiliated with this study and their
immediate families. Immediate family is defined as a spouse, parent, child or sibling,
whether biological or legally adopted.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Renal Research - Gosford
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
Westmead - Westmead
Recruitment hospital [5] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 0 0
Austion Hospital - Heidelberg
Recruitment hospital [9] 0 0
Sunshine Hospital - Melbourne
Recruitment hospital [10] 0 0
Melbourne Renal Research Group - Melbourne
Recruitment hospital [11] 0 0
Epworth Hospital - Richmond
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4575 - Birtinya
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
3021 - Melbourne
Recruitment postcode(s) [10] 0 0
- Melbourne
Recruitment postcode(s) [11] 0 0
3121 - Richmond

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Dimerix Bioscience Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Iqvia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT03649152
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Simon Roger, MD
Address 0 0
Renal Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications