A randomized double-blind parallel placebo trial to evaluate the efficacy and safety of sulodexide on diabetes with marcoalbuminuria.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-09000559

Enrollment

Unknown

Registered

2009-10-01

Start date

2009-10-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes with marcoalbuminuria

Interventions

Placebo group:Placebo 2 capsules bid for 48 weeks

Sulodexide group:Sulodexide 2 capsules bid (100mg/day) for 48 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Consistent with the 1997 ADA criteria in patients with type 2 diabetes mellitus; 2. Consistent with the 2007 KDOQI criteria on the Diabetic nephropathy; 3. To be aged from 18 to 70 years; 4. Male or female; 5. Marcoalbuminuria. ACR (Albumin creatinine ratio) >300 mg/g or albuminuria >300mg/24hour; 6. Stability of glycometabolism more than 3 months: HbA1c=60ml/min (MDRD Formula); 9. Plasma albumin>=30g/L; 10. Signed informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. Albuminuria >3.5g/24hour; 2. Diabetes with non-diabetic kidney disease, kidney transplant patients; 3. Severe diabetes complications such as ketoacidosis, severe diabetic foot, etc; 4. More than 3 months history of unstable angina, myocardial infarction, coronary artery bypass surgery or percutaneous coronary stent implantation, transient ischemic attacks (TIA), stroke, NYHA III ~ IV grade, obstructive valvular disease; hypertrophic cardiomyopathy, pacemaker implantation due to II ~ III degree atrioventricular block; 5. Need immunosuppressive agents; 6. Primary or recurrence tumor; 7. Incompatible patients, i.e. mental disorders; 8. Intolerance oral administration or sever malabsorption; 9. Drug addiction or HIV; 10. liver dysfunction: TIBL>35umol/L or transaminase > 2 times upper limit; 11. Allergy to glycosaminoglycan or ARBs, or easy allergy; 12. Abnormality of blood system or easy bleeding; 13. Uncontrollable urinary tract infections due to bias the albuminuria; 14. Pregnancy or breast-feeding; 15 Participate into other clinical trials unless interval more than 30 days; 16. Survival > 1 year.

Design outcomes

Primary

Measure	Time frame
ACR change;Improvemen;	—

Secondary

Measure	Time frame
GFR;24-hour urinary protein;VCAM-1;ICAM-1;PCR;AC;	—

Countries

China

Contacts

Public ContactPing Fu

fupinghx@vip.163.com+86 028 81812201

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026