The Collaborative Study Group Trial: The Effect of Sulodexide in Overt Type 2 Diabetic NephropathyThe Collaborative Study Group Trial: El efecto de Sulodexide en la Nefropatia Diabética manifiesta Tipo 2. - Sulodexide in Overt Type 2 Diabetic Nephropathy

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-13
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

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

Inclusion Criteria

1.The patient must be diagnosed with type 2 diabetes:
2.The patient must be diagnosed with diabetic nephropathy as defined by PCR of three first void AM urine samples equal to or greater than 900 mg/G in woman and 650 mg/G in men at Visit 2. Serum creatinine in woman between 1.3 and 3.0 mg/dL, inclusive, and men between 1.5 and 3.0 mg/dL, inclusive, at Visit 1. If the screening serum creatinine falls outside the specified creatinine criteria, a patient may enter the Run-un Period if the GFR by the MDRD formula at Visit 1 is between 25 to 45 mL/min.

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 Angiotensin-converting enzyme inhibitor (ACEI) and Angiotensin receptor blocker (ARB);

4.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;

5.Need for chronic (>2 weeks) immunosuppressive therapy, including corticosteroids (excluding inhaled or nasal steroids);
6.Known allergies or intolerance to any heparin-like compound including heparin-induced thrombocytopenia Type II;
7.Prior exposure to sulodexide, either in a clinical setting or as a participant in another clinical study.
8.Untreated urinary tract infection or other medical condition that may impact urinary protein values.

Study & Design

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