Chronic Kidney DiseasePhase 3DEFINENCT01000545
The Efficacy and Safety Study of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease
A Phase 3 study testing Sulodexide in people with Chronic Kidney Disease, run by Corbridge Group Philippines, Inc. at 7 sites in Philippines.
Trial summary
The purpose of this study is to determine the effect and safety of Sulodexide in Filipino patients with Chronic Kidney Disease (CKD). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Sulodexide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,508 participants
- Where
- 7 sitesPhilippines
- Study dates
- Nov 2009to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Philippines7 sites
Holy Child Hospital
Dumaguete
Kenneth Coo
Mary Mediatrix Medical Center
Lipa City, Batangas
Edgardo Faustino, MD
Victoriano R. Potenciano Medical Center
Mandaluyong
Antonietta D Dial, M.D.
Metropolitan Medical Center
Manila
Susan Y Gan, MD
Rizal Private Clinics
Metro Manila, Rizal
Manila Adventist Medical Center
Pasay
Gingerlita Samonte, MD
The Medical City
Pasig
Elizabeth R Sebastian, MD, FPSN
About this study
Official title: The Efficacy and Safety of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease: A Randomized Controlled Trial
The purpose of this study is to determine the effect and safety of Sulodexide in Filipino patients with Chronic Kidney Disease (CKD).
- Conditions
- Chronic Kidney Disease
- Being tested
- Sulodexide, placebo capsules
- Keywords
- Diabetes Mellitus, Chronic Kidney Disease, Glycosaminoglycans, Sulodexide, Macroalbuminuria, Safety and Efficacy
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulodexideDrug
Also called Vessel Due-F, SLX, Glycosaminoglycans
SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
placebo capsulesDrug
Also called placebo, placebo gelcaps
8 soft-gel capsules per day to be taken orally for 12 months
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: Sulodexide |
What is being measured
The primary outcome is the main question the study is designed to answer.
macroalbuminuria and serum creatinine
Measured: 52 weeks
Secondary outcomes (1)
adverse events
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corbridge Group Philippines, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Alfasigma S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000545
- Sponsor's protocol ID
- SLD-CKD-001
- Acronym
- DEFINE
- Status last verified
- Oct 2009
- First submitted
- 22 Oct 2009
- Last updated
- 30 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01000545
- Acronym / sponsor ID
- DEFINE / SLD-CKD-001
- Conditions
- Chronic Kidney Disease
- Keywords
- Diabetes Mellitus, Chronic Kidney Disease, Glycosaminoglycans, Sulodexide, Macroalbuminuria, Safety and Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,508 participants (estimated)
- Lead sponsor
- Corbridge Group Philippines, Inc.University, hospital or other
- Collaborators
- Alfasigma S.p.A.
- Study start
- Nov 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect and safety of Sulodexide in Filipino patients with Chronic Kidney Disease (CKD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo gelcaps + best medical treatment | Placebo comparator | Drug: placebo capsulesPatient 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) |
| SLX 500LRU/day + best medical treatment | Active comparator | Drug: SulodexidePatient 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) |
| SLX 1000LRU/day + best medical treatment | Active comparator | Drug: SulodexidePatient 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) |
| SLX 2000LRU/day + best medical treatment | Active comparator | Drug: SulodexidePatient 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) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SulodexideAlso: Vessel Due-F, SLX, GlycosaminoglycansSLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months. | Drug | SLX 1000LRU/day + best medical treatment, SLX 2000LRU/day + best medical treatment, SLX 500LRU/day + best medical treatment |
| placebo capsulesAlso: placebo, placebo gelcaps8 soft-gel capsules per day to be taken orally for 12 months | Drug | placebo gelcaps + best medical treatment |
Primary outcome
macroalbuminuria and serum creatinine
Time frame: 52 weeks
1 secondary outcome
adverse events
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sulodexide in people with Chronic Kidney Disease, run by Corbridge Group Philippines, Inc. at 7 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arlene C Crisostomo, M.D., MSc. (639189004532, arlene_crisostomo_md@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
macroalbuminuria and serum creatinine (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2009.