Chronic Kidney Disease
Conditions
Keywords
Diabetes Mellitus, Chronic Kidney Disease, Glycosaminoglycans, Sulodexide, Macroalbuminuria, Safety and Efficacy
Brief summary
The purpose of this study is to determine the effect and safety of Sulodexide in Filipino patients with Chronic Kidney Disease (CKD).
Interventions
DRUGSulodexide
SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
DRUGplacebo capsules
8 soft-gel capsules per day to be taken orally for 12 months
Sponsors
Alfasigma S.p.A.
Corbridge Group Philippines, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| macroalbuminuria and serum creatinine | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| adverse events | 52 weeks |
Countries
Philippines
Contacts
Primary ContactArlene C Crisostomo, M.D., MSc.
Backup ContactKathrina B Imperial
Outcome results
None listed