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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03627715




Registration number
NCT03627715
Ethics application status
Date submitted
7/08/2018
Date registered
13/08/2018

Titles & IDs
Public title
Safety and Effectiveness of Propagermanium in Diabetic Kidney Disease Participants Receiving Irbesartan
Scientific title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients With Diabetic Kidney Disease (DKD) Who Are Receiving Irbesartan
Secondary ID [1] 0 0
ACTRN12618000982213p
Secondary ID [2] 0 0
DMX-200-203 A
Universal Trial Number (UTN)
Trial acronym
ACTION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

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 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.

Experimental: Placebo then Propagermanium - 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.


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 Change in Albumin/Creatinine Ratio with Adjunct use of Propagermanium Compared to Placebo in Participants with DKD who are Receiving Irbesartan
Timepoint [1] 0 0
Twelve weeks
Secondary outcome [1] 0 0
The Effect of Treatment with Propagermanium Compared to Placebo on Measures of Estimated Glomerular Filtration Rate
Timepoint [1] 0 0
Twelve weeks
Secondary outcome [2] 0 0
The Number of Adverse Events with the Adjunct use of Propagermanium
Timepoint [2] 0 0
Twelve weeks
Secondary outcome [3] 0 0
The Effect of Treatment with Propagermanium on Measures of Proteinuria as measured by ACR
Timepoint [3] 0 0
Eleven 24-hour urine samples at week -2, week -1, week 6, week 11, week 12.

Eligibility
Key inclusion criteria
1. Aged 18 to 90 (inclusive) at screening;
2. A diagnosis of type 2 diabetes mellitus;
3. Baseline glycated haemoglobin (HbA1c) = 12%;
4. Fasting plasma glucose < 21 mmol/L;
5. 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;
6. 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;
7. 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;
8. 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;
9. 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
10. 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;
11. 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;
12. Have given written informed consent prior to any study procedures being performed.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A history of type 1 diabetes mellitus;
2. Current known non-diabetic renal disease. Patients with a history of other resolved renal diseases must be approved by the Sponsor;
3. A prior organ or stem cell transplant;
4. A major adverse cardiac event within 6 months before screening;
5. Patients receiving immunosuppressive medications including patients receiving > 5 mg prednisone;
6. Rapid estimated glomerular filtration rate decline with renal replacement likely during study
7. 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;
8. Jaundice, active hepatitis, or known hepatobiliary disease (except asymptomatic cholelithiasis);
9. Alanine aminotransferase and/or aspartate aminotransferase more than two times the upper limit of normal at screening;
10. 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;
11. Positive screening assessment for viral hepatitis B surface antigen or hepatitis C virus (HCV) antibody AND positive HCV ribonucleic acid or human immunodeficiency virus (HIV);
12. Seated blood pressure of more than or equal to 160/100 mmHg at screening;
13. Body mass index more than or equal to 42 kg/m^2 at screening;
14. Past hospitalisation for a major depressive episode;
15. Is breast feeding or pregnant;
16. Unable to comply with the study procedures and assessments, including the ability swallow capsules;
17. 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;
18. 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/08/2020
Sample size
Target
Accrual to date
Final
45
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 Hospital - 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
Boxhill Hospital - Box Hill
Recruitment hospital [8] 0 0
Austin 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
Royal Melbourne Hospital - Melbourne
Recruitment hospital [12] 0 0
St Vincents Hospital - Melbourne
Recruitment hospital [13] 0 0
Epworth Hospital - Richmond
Recruitment postcode(s) [1] 0 0
- 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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03627715