THE COLLABORATIVE STUDY GROUP TRIAL: THE EFFECT OF SULODEXIDE IN PATIENTS WITH TYPE 2 DIABETES AND MICROALBUMINURIAEnsayo del grupo Collaborative Study Group: el efecto de sulodexida en pacientes con diabetes tipo 2 y microalbuminuria - Sulodexide in Type 2 Diabetes with Microalbuminuria

Phase 1

• Conditions: Type 2 Diabetic Microalbuminuria; MedDRA version: 8.0Level: LLTClassification code 10027525

• Registration Number: EUCTR2005-003158-91-ES
• Lead Sponsor: Keryx Biopharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-15
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

The principle inclusion criteria for the study includes men and women with type 2 diabetes and persistent microalbuminuria (in men urine albumin creatinine ratio [ACR] 35 – 200 mg albumin/G creatinine [4.0 - 22.6 mg/mmol], in women urine ACR 45 – 200 mg albumin/G creatinine [5.1 – 22.6 mg/mmol] based on the geometric mean of 3 first voided AM urine samples at the qualifying visit [Visit 6]). Patient’s serum creatinine must be less than or equal to 1.5 mg/dL at screening.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Age of onset of type 2 diabetes <18 years;

2.HbA1C >10.0%;

3.Morbid obesity defined as a body mass index (BMI) more than or equal to 45 kg/m2;

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

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

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

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

8.Untreated urinary tract infection that would impact urinary protein values; or

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

Study & Design

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