The Collaborative Study Group Trial: The Effect of Sulodexide in Overt Type 2 Diabetic Nephropathy - Sulodexide in Overt Type 2 Diabetic Nephropathy

• Conditions: Overt Type 2 Diabetic Nephropathy; MedDRA version: 8.0Level: LLTClassification code 10061835

• Registration Number: EUCTR2005-002095-15-BE
• Lead Sponsor: Keryx Biopharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-27
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2240

Inclusion Criteria

1. Males and non-lactating and non-pregnant females. Females must be post-menopausal, surgically sterile, or using adequate contraception. All women of child-bearing potential must have a negative serum pregnancy test (minimum sensitivity 25 IU/L of ß-HCG) at Visit 1 and within 72 hours prior to the start of study medication;

2. Diagnosis of type 2 diabetes as defined by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus;

3. Age 18 years old. Upper age limit is at the discretion of the investigator and should be based on the judgment of the investigator that the patient is likely to survive at least 2 years;

4. Total protein from a 24-hour urine collection at Visit 2 is equal or more than 900 mg/24 hr (equal or more than 0.9 G/24 hr);

5. Serum creatinine in women between 1.3 and 3.0 mg/dL (115-265 µmol/L), inclusive, and in men between 1.5 and 3.0 mg/dL (133-265 µmol/L), inclusive, at Visit 1. If the screening serum creatinine falls outside the specified creatinine criteria, a patient may enter the Run-in Period if the GFR by the MDRD formula at Visit 1 is between 25 to 45mL/min;

6. Willing to discontinue antihypertensive medication regimen, if applicable.

7. Willing and able to give informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

2.Renal disease as follows:·Patients with known non-diabetic renal disease (nephrosclerosis superimposed on diabetic nephropathy acceptable), or·Renal allograft;

3.Absolute requirement for combination therapy of ACEI and ARB;

4.Patients who require ACEI, but not ACEI/ARB combination, may enter the trial if approved by the Clinical Coordinating Center;

5.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;

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

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

8.Psychiatric disorder that interferes with the patient’s ability to comply with the protocol;

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

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

11.Known human immunodeficiency virus disease;

12.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;

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

14.Evidence of hepatic dysfunction including total bilirubin >2.0 mg/dL (>35 mmol/L) or liver transaminase (aspartate aminotransferase [AST] or alanine transferase [ALT]) >3 times upper limit of normal at Screening;

15.Anticipate need for surgery;

16.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);

17.Known allergies or intolerance to any heparin-like compound including heparin-induced thrombocytopenia Type II;

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

19. Untreated urinary tract infection that may impact urinary protein values.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified