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

Sponsor

Corbridge Group Philippines, Inc. (Other)

Overall Status

Unknown status

CT.gov ID

NCT01000545

Collaborator

Alfasigma S.p.A. (Industry)

1,508

Enrollment

Locations

Arms

Duration (Months)

215.4

Patients Per Site

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Drug: Sulodexide Drug: placebo capsules	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1508 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2009

Anticipated Primary Completion Date :

Jan 1, 2011

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo gelcaps + best medical treatment Patient will receive 4 placebo gelcaps twice a day. Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)	Drug: placebo capsules 8 soft-gel capsules per day to be taken orally for 12 months Other Names: placebo placebo gelcaps
Active Comparator: SLX 500LRU/day + best medical treatment Patient will receive 1 SLX gelcap and 3 placebo gelcaps twice a day.Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)	Drug: Sulodexide SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months. Other Names: Vessel Due-F SLX Glycosaminoglycans
Active Comparator: SLX 1000LRU/day + best medical treatment Patient will receive 2 SLX gelcaps and 2 placebo gelcaps twice a day. Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)	Drug: Sulodexide SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months. Other Names: Vessel Due-F SLX Glycosaminoglycans
Active Comparator: SLX 2000LRU/day + best medical treatment Patient will receive 4 SLX gelcaps twice a day. Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)	Drug: Sulodexide SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months. Other Names: Vessel Due-F SLX Glycosaminoglycans

Outcome Measures

Primary Outcome Measures

macroalbuminuria and serum creatinine [52 weeks]

Secondary Outcome Measures

adverse events [52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Mary Mediatrix Medical Center	Lipa City	Batangas	Philippines
2	Rizal Private Clinics	Metro Manila	Rizal	Philippines
3	Holy Child Hospital	Dumaguete City		Philippines
4	Victoriano R. Potenciano Medical Center	Mandaluyong City		Philippines
5	Metropolitan Medical Center	Manila		Philippines
6	Manila Adventist Medical Center	Pasay City		Philippines
7	The Medical City	Pasig City		Philippines