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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00130208




Registration number
NCT00130208
Ethics application status
Date submitted
11/08/2005
Date registered
15/08/2005
Date last updated
23/03/2018

Titles & IDs
Public title
Effect of Sulodexide in Early Diabetic Nephropathy
Scientific title
The Collaborative Study Group Trial: The Effect of Sulodexide in Patients With Type 2 Diabetes and Microalbuminuria
Secondary ID [1] 0 0
KRX-101-301
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
Treatment: Drugs - Placebo

Experimental: Sulodexide - Also known as KRX-101. All patients will be on standard of care ACE or ARBs.

Placebo Comparator: Placebo - All patients will be on standard of care ACE or ARBs.


Treatment: Drugs: Sulodexide
100 mg sulodexide gelcaps

Treatment: Drugs: Placebo
0 mg gelcap

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

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Conversion From Microalbuminuria to Normoalbuminuria - The primary efficacy variable was the fraction of those patients in the ITT population with valid baseline and Week 26 ACRs in whom "therapeutic success" was achieved at Week 26 measured as a conversion of microalbuminuria to normoalbuminuria and at least a 25% reduction in ACR relative to baseline
Timepoint [1] 0 0
26 Weeks
Primary outcome [2] 0 0
Number of Subjects With Greater Than 50% Reduction in Microalbuminuria - During the treatment period, KRX-101 is being compared to placebo to assess whether a 50% reduction in microalbuminuria has been achieved.
Timepoint [2] 0 0
26 Weeks
Secondary outcome [1] 0 0
Change in Serum Albumin From Baseline to End of 26 Weeks
Timepoint [1] 0 0
26 Weeks

Eligibility
Key inclusion criteria
- Diagnosis of type 2 diabetes

- Serum creatinine equal to or less than 1.5 mg/dL

- Microalbuminuria, defined by a urine albumin/creatinine ratio in men; 35- 200 mg
albumin/G creatinine, in women; 45-200 mg albumin/G creatinine

- Blood pressure controlled to less than 150/90 mmHg

- Willing to change antihypertensive medication regimen if necessary
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Age of onset of type 2 diabetes <18 years;

- HbA1C >10.0%;

- Morbid obesity defined as a body mass index (BMI) >= 45 kg/m2;

- Type 1 (insulin-dependent; juvenile onset) diabetes;

- Renal disease as follows:

- Patients with known non-diabetic renal disease

- Renal allograft

- Absolute requirement for combination therapy of angiotensin converting enzyme
inhibitors (ACEI) and angiotensin receptor blockers (ARB);

- Cardiovascular disease as follows:

- Unstable angina pectoris within 3 months of study entry;

- Myocardial infarction, coronary artery bypass graft surgery, or percutaneous
transluminal coronary angioplasty or stent placement within 3 months of study
entry;

- Transient ischemic attack within 3 months of study entry;

- Cerebrovascular accident within 3 months of study entry;

- Symptomatic heart failure requiring ACE inhibition;

- New York Heart Association Functional Class III or IV heart failure;

- Obstructive valvular heart disease or hypertrophic cardiomyopathy;

- Second or third degree atrioventricular block not successfully treated with a
pacemaker

- Need for chronic (>2 weeks) immunosuppressive therapy, including corticosteroids
(excluding inhaled or nasal steroids);

- History of multiple drug allergies;

- New diagnosis of cancer or recurrent cancer within 5 years of screening ( (except
non-melanoma skin cancer);

- Psychiatric disorder that interferes with the patient's ability to comply with the
protocol;

- Inability to tolerate oral medication or a history of significant malabsorption;

- Inability to remain on a stable dose of the following class of medications 30 days
prior to randomization and throughout the study:

- 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins);

- Peroxisome proliferator-activated receptor gamma (PPAR gamma inhibitors
(glitazones);

- Cyclooxygenase-2 inhibitors (COX-2 inhibitors); or

- Non-steroidal anti-inflammatory drugs (NSAIDS);

- History of alcohol or other drug abuse within 12 months of study entry;

- Known human immunodeficiency virus (HIV) disease;

- Any other medical condition which renders the patient unable to or unlikely to
complete the study, or which would interfere with optimal participation in the study
or produce significant risk to the patient;

- Receipt of any investigational drugs (including placebo) within 30 days of enrollment;

- Evidence of hepatic dysfunction including total bilirubin >2.0 mg/dL or liver
transaminase (AST or ALT) >3 times upper limit of normal;

- Anticipated surgery within trial period;

- Inability to cooperate with study personnel or history of noncompliance to medical
regimen (i.e., patients who would be expected to comply poorly with treatment);

- Known allergies or intolerance to any heparin-like compound;

- Untreated urinary tract infection that would impact urinary protein values; or

- Prior exposure to sulodexide, either in a clinical setting or as a participant in
another clinical study.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
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
The Collaborative Study Group, Clinical Coordinating Center for the Pacific Region, Monash Medical Center - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
Netherlands
State/province [2] 0 0
Groningen

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 the study is to determine whether treatment with sulodexide is effective in
reducing the level of urine albumin excretion in patients with early diabetic kidney disease
expressed as microalbuminuria.
Trial website
https://clinicaltrials.gov/show/NCT00130208
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edmund J Lewis, M.D.
Address 0 0
The Collaborative Study Group, Rush University Medical Center, Chicago, IL USA
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