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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02010242




Registration number
NCT02010242
Ethics application status
Date submitted
18/06/2013
Date registered
12/12/2013
Date last updated
30/03/2015

Titles & IDs
Public title
Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria
Scientific title
A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study Evaluating the Safety and Efficacy of Oral GKT137831 in Patients With Type 2 Diabetes and Albuminuria
Secondary ID [1] 0 0
GSN000200
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus With Diabetic Nephropathy 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GKT137831
Treatment: Drugs - Placebo

Experimental: GKT137831 - GKT137831 100 mg capsules twice a day

Placebo Comparator: Placebo - Placebo capsule twice a day


Treatment: Drugs: GKT137831
1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment

Treatment: Drugs: Placebo
1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Albuminuria
Timepoint [1] 0 0
Visits 4 (week -2), 5 (week 0), 6 (week 2), 7 (week 4), 8 (week 6), 9 (week 8), 10 (week 10), 11 (week 12), and 12 (week 16)
Secondary outcome [1] 0 0
Glucose metabolism
Timepoint [1] 0 0
Visits 5 (week 0), 8 (week 6), and 11 (week 12)

Eligibility
Key inclusion criteria
Key

- Male or female aged 18 to 80 years

- History of type 2 diabetes, defined as fasting plasma glucose =7.0 mmol/L (126 mg/dL)
or a glycated hemoglobin (HbA1c) >6.5% (48 mmol/mol) on at least 2 occasions prior to
screening.

- Albuminuria defined as a UACR of 300 to 3500 mg/g.

- An eGFR =30 mL/min/1.73 m2, as calculated by the CKD-EPI formula.

- Must be taking an ACEI or an ARB for at least 6 weeks prior to the first screening
visit (Visit 1) and during the screening period. The dose must have been stable for at
least 4 weeks prior to the first screening visit (Visit 1). Combination therapy
associating an ACEI and an ARB is not permitted.

Key
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of type 1 diabetes

- Any other non-diabetic kidney disease(s) except for hypertensive nephropathy which is
acceptable.

- Diagnostic or interventional procedure requiring a contrast agent within 4 weeks of
the first screening visit (Visit 1) or planned during the study.

- History of renal transplant or planned renal transplant during the study.

- A history of acute renal dialysis or acute kidney injury (defined according to the
Kidney Disease: Improving Global Outcomes [KDIGO] definition) within 12 weeks of the
first screening visit (Visit 1)

- HbA1c level >11% (97 mmol/mol).

- History of hypothyroidism requiring hormone replacement therapy.

- History of active cardiovascular disease

- A personal or family history of long QT syndrome.

- Administration of any investigational product within 30 days or within 5 half-lives of
the investigational agent

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
Parallel
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
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Marrondah ECRU - East Ringwood
Recruitment hospital [3] 0 0
Deakin University school of medicine - Geelong
Recruitment hospital [4] 0 0
Austin Health - Heidelberg
Recruitment hospital [5] 0 0
Baker Institute - Melbourne
Recruitment hospital [6] 0 0
Captain Stirling Medical Centre - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3135 - East Ringwood
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Huzova
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Novy Bydzov
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Olomouc
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Prague
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Praha
Country [21] 0 0
Germany
State/province [21] 0 0
Aschaffenburg
Country [22] 0 0
Germany
State/province [22] 0 0
Elsterwerda
Country [23] 0 0
Germany
State/province [23] 0 0
Mainz
Country [24] 0 0
Germany
State/province [24] 0 0
Munchen
Country [25] 0 0
Poland
State/province [25] 0 0
Gdansk
Country [26] 0 0
Poland
State/province [26] 0 0
Krakow
Country [27] 0 0
Poland
State/province [27] 0 0
Opole
Country [28] 0 0
Poland
State/province [28] 0 0
Poznan
Country [29] 0 0
Poland
State/province [29] 0 0
Staszow
Country [30] 0 0
Poland
State/province [30] 0 0
Szczecin
Country [31] 0 0
Poland
State/province [31] 0 0
Warsaw

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Calliditas Therapeutics AB
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
NADPH oxidase enzymes (NOX) have been implicated in the development of several diabetic
complications including diabetic nephropathy. GKT137831 is the first in class NOX1/4
inhibitor.

The primary objective of this study is to evaluate the efficacy of oral GKT137831 in patients
with residual albuminuria despite maximal inhibition of the renin angiotensin aldosterone
system.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02010242
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philippe Wiesel, MD
Address 0 0
Calliditas Therapeutics AB
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02010242