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NCT01000545 Clinical Trial

The Efficacy and Safety Study of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

— DEFINE  

Official title:
The Efficacy and Safety of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01000545
Other study ID # SLD-CKD-001
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received October 22, 2009
Last updated October 29, 2009
Start date November 2009
Est. completion date December 2012

Study information
Verified date October 2009
Source Corbridge Group Philippines, Inc.
Contact Arlene C Crisostomo, M.D., MSc.
Phone 639189004532
Email arlene_crisostomo_md@yahoo.com
Is FDA regulated No
Health authority Philippines: Bureau of Food and DrugsPhilippines: Philippine Council for Health Research and Development
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect and safety of Sulodexide in Filipino patients with Chronic Kidney Disease (CKD).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1508
Est. completion date December 2012
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Type 2 diabetes mellitus

- positive 2 of 3 ACR > 300 mg/g or 24h urine protein or albumin collection > 300 mg/d in the absence of urinary tract infection

- serum creatinine 1.3 - 3 mg/dl in women and 1.5 - 3 mg/dl in men

Exclusion Criteria:

- age of onset of DM \< 18 years

- + renal disease like non-DM renal disease

- + CV diseases such as UA, MI, CABG

- + CVA or TIA within last 6 months

- untreated UTI

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Sulodexide
SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
• placebo capsules
8 soft-gel capsules per day to be taken orally for 12 months

Locations
Country Name City State
Philippines Holy Child Hospital Dumaguete City
Philippines Mary Mediatrix Medical Center Lipa City Batangas
Philippines Victoriano R. Potenciano Medical Center Mandaluyong City
Philippines Metropolitan Medical Center Manila
Philippines Rizal Private Clinics Metro Manila Rizal
Philippines Manila Adventist Medical Center Pasay City
Philippines The Medical City Pasig City

Sponsors (2)
Lead Sponsor Collaborator
Corbridge Group Philippines, Inc. Alfa Wassermann S.p.A.

Country where clinical trial is conducted

Philippines, 

Outcome
Type Measure Description Time frame Safety issue
Primary macroalbuminuria and serum creatinine 52 weeks Yes
Secondary adverse events 52 weeks Yes
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