NCT01000545

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,508

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2009

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 30, 2009

Status Verified

October 1, 2009

Enrollment Period

1.2 years

First QC Date

October 22, 2009

Last Update Submit

October 29, 2009

Conditions

Chronic Kidney Disease

Keywords

Diabetes MellitusChronic Kidney DiseaseGlycosaminoglycansSulodexideMacroalbuminuriaSafety and Efficacy

Outcome Measures

Primary Outcomes (1)

  • macroalbuminuria and serum creatinine

    52 weeks

Secondary Outcomes (1)

  • adverse events

    52 weeks

Study Arms (4)

placebo gelcaps + best medical treatment

PLACEBO COMPARATOR

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

SLX 500LRU/day + best medical treatment

ACTIVE COMPARATOR

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 1000LRU/day + best medical treatment

ACTIVE COMPARATOR

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 2000LRU/day + best medical treatment

ACTIVE COMPARATOR

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

Interventions

SulodexideDRUG

SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.

Also known as: Vessel Due-F, SLX, Glycosaminoglycans
SLX 1000LRU/day + best medical treatmentSLX 2000LRU/day + best medical treatmentSLX 500LRU/day + best medical treatment
placebo capsulesDRUG

8 soft-gel capsules per day to be taken orally for 12 months

Also known as: placebo, placebo gelcaps
placebo gelcaps + best medical treatment

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Mary Mediatrix Medical Center

Lipa City, Batangas, Philippines

Location

Rizal Private Clinics

Metro Manila, Rizal, Philippines

Location

Holy Child Hospital

Dumaguete, Philippines

Location

Victoriano R. Potenciano Medical Center

Mandaluyong, Philippines

Location

Metropolitan Medical Center

Manila, Philippines

Location

Manila Adventist Medical Center

Pasay, Philippines

Location

The Medical City

Pasig, Philippines

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes Mellitus

Interventions

glucuronyl glucosamine glycan sulfateGlycosaminoglycans

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PolysaccharidesCarbohydrates

Central Study Contacts

Arlene C Crisostomo, M.D., MSc.

CONTACT

639189004532arlene_crisostomo_md@yahoo.com

Kathrina B Imperial

CONTACT

6324487933kaye_imperial2004@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2009

First Posted

October 23, 2009

Study Start

November 1, 2009

Primary Completion

January 1, 2011

Study Completion

December 1, 2012

Last Updated

October 30, 2009

Record last verified: 2009-10

Locations

PH(7)