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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00462202




Registration number
NCT00462202
Ethics application status
Date submitted
16/04/2007
Date registered
18/04/2007
Date last updated
3/03/2017

Titles & IDs
Public title
Open Label Tolerability and Safety Study of KRX-101 in Australia, New Zealand, and Hong Kong
Scientific title
An Open Label Tolerability and Safety Study of KRX-101 (Sulodexide Gelcaps) for the Treatment of Type 2 Diabetic Nephropathic Patients With Persistent Microalbuminuria in Australia, New Zealand, and Hong Kong
Secondary ID [1] 0 0
KRX 101-302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Nephropathy 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 - sulodexide

Experimental: Sulodexide - Open label extension to original trial


Treatment: Drugs: sulodexide


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

Outcomes
Primary outcome [1] 0 0
Observed ACR level from the first visit to the end of study - Open label safety extension to assess long-term exposure to sulodexide (KRX-101) in patients with albumin and protein in their urine.
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
- At least 18 years of age and has successfully completed Keryx Study 101-301.

- Diagnosis of DM2 based on ADA criteria.

- Continued stable seated systolic blood pressure < 150 mmHg and diastolic blood
pressure < 90 mmHg.

- Provide written informed consent to participate in the study.

- If female and of childbearing potential, must continue to be willing to use adequate
contraception, as determined by the investigator, for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Evidence of hepatic dysfunction including total bilirubin > 2.0 mg/dL (34 micromol/L)
or liver enzymes > 3 times upper limit of normal.

- Unstable angina pectoris or New York Heart Association Class III or IV congestive
heart failure.

- A history of any major medical condition, including but not limited to: aortic
aneurysm; myocardial infarction, stroke, or other cardiovascular events in the past 3
months; gastrointestinal bleeding in the past 3 months; HIV; and other medical
conditions deemed serious by the investigator. Active Hepatitis B or C (currently
active disease defined as an abnormal liver biopsy or persistent, elevated
transaminases, SGOT, SGPT).

- Any risk of bleeding, including a history of bleeding diathesis and a platelet count <
100,000/mm³.

- Active or metastatic cancer (note: superficial basal carcinoma of the skin is not an
exclusion).

- Anticipated surgery within trial period.

- History of noncompliance to medical regimens in Keryx Study No.101-301.

- Participation in any experimental drug study in the past 60 days, except for
KRX-101-301, prior to entry into the study, or plan to participate in any experimental
drug study during the study period.

- Lactation, pregnancy, or an anticipated or planned pregnancy during the study period.

- Known allergy or intolerance to any heparin-like compounds.

- Patients with other specific renal diseases known to be the cause of nephropathy, and
patients with other specific, clinically significant renal disease.

- Inability to give an informed consent or cooperate with the study personnel.

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
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)
VIC
Recruitment hospital [1] 0 0
Monash Medical Center - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Keryx Biopharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Collaborative Study Group (CSG)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the tolerability and safety of KRX-101 in treating
persistent microalbuminuria in type 2 diabetic patients who are also being treated with
stable, maximum tolerated doses of either ACE inhibitors or A2 receptor blockers.
Trial website
https://clinicaltrials.gov/show/NCT00462202
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Atkins, MD
Address 0 0
Monash Medical Centre
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/show/NCT00462202