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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00130312




Registration number
NCT00130312
Ethics application status
Date submitted
11/08/2005
Date registered
15/08/2005

Titles & IDs
Public title
Effect of Sulodexide in Overt Diabetic Nephropathy
Scientific title
The Collaborative Study Group Trial: The Effect of Sulodexide in Overt Type 2 Diabetic Nephropathy
Secondary ID [1] 0 0
KRX-101-401
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. These patients are also on ACEs and ARBs (irbesartin and/or losartan).

Placebo comparator: Placebo - These patients are also on ACEs and ARBs (irbesartin and/or losartan).


Treatment: Drugs: Sulodexide
100 mg gelcap in the morning and evening

Treatment: Drugs: Placebo
1 placebo gelcap in the morning and evening
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to doubling of the serum creatinine or end stage kidney disease (ESRD)
Timepoint [1] 0 0
Time in study depended on time to doubling of serum creatinine
Primary outcome [2] 0 0
Safety and tolerance of sulodexide therapy long-term
Timepoint [2] 0 0
Time in study depended on time to doubling of serum creatinine
Secondary outcome [1] 0 0
Change in urinary protein/albumin excretion
Timepoint [1] 0 0
Time in study depended on time to doubling of serum creatinine

Eligibility
Key inclusion criteria
* Diagnosis of type 2 diabetes;
* Urine protein to creatinine ratio (PCR) equal to or greater than 900 mg/G (101.7 mg/mmol) in women and equal to or greater than 650 mg/G (73.45 mg/mmol) in men;
* Serum creatinine in women 1.3 - 3.0 mg/dL (115-265 µmol/L), inclusive, and in men 1.5 - 3.0 mg/dL (133-265 µmol/L), inclusive;
* Willing to discontinue antihypertensive medication regimen, if applicable;
* Willing and able to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Type 1 (insulin-dependent; juvenile onset) diabetes;
* Renal disease as follows:

* Patients with known non-diabetic renal disease (nephrosclerosis superimposed on diabetic nephropathy acceptable), or
* Renal allograft;
* Absolute requirement for combination therapy of angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB);
* Patients who require ACEI, but not ACEI/ARB combination;
* 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/stent within 3 months of study entry;
* Transient ischemic attack within 3 months of study entry;
* Cerebrovascular accident within 3 months of study entry;
* New York Heart Association Functional Class III or IV (Note: if a patient is New York Heart Association Functional Class I or II and requires an ACEI, consult with the Clinical Coordinating Center to obtain permission for the patient to be on an ACEI rather than an ARB);
* Obstructive valvular heart disease or hypertrophic cardiomyopathy; or
* 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);
* 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;
* History of alcohol or other drug abuse within 12 months of study entry;
* Known human immunodeficiency virus 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 (>35 micromol/L) or liver transaminase (aspartate aminotransferase [AST] or alanine transferase [ALT]) >3 times upper limit of normal;
* Anticipate need for surgery;
* Inability to cooperate with study personnel or history of noncompliance to medical regimen;
* Known allergies or intolerance to any heparin-like compound including heparin-induced thrombocytopenia Type II;
* Prior exposure to sulodexide, either in a clinical setting or as a participant in another clinical study.
* Untreated urinary tract infection that would impact urinary protein values.

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 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
968
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edmund J Lewis, MD
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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/NCT00130312