Diabetic NephropathyPhase 3NCT00462202
Open Label Tolerability and Safety Study of KRX-101 in Australia, New Zealand, and Hong Kong
A Phase 3 study testing sulodexide in people with Diabetic Nephropathy, run by Keryx Biopharmaceuticals at 1 site in Australia.
Trial summary
The purpose of this study is to assess the tolerability and safety of KRX-101 in treating persistent microalbuminuria in type 2 diabetic patients who are also being treated with stable, maximum tolerated doses of either ACE inhibitors or A2 receptor blockers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- sulodexide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2007to Mar 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age and has successfully completed Keryx Study 101-301.
- Diagnosis of DM2 based on ADA criteria.
- Continued stable seated systolic blood pressure < 150 mmHg and diastolic blood pressure < 90 mmHg.
- Provide written informed consent to participate in the study.
- If female and of childbearing potential, must continue to be willing to use adequate contraception, as determined by the investigator, for the duration of the study.
Who cannot join
- Evidence of hepatic dysfunction including total bilirubin > 2.0 mg/dL (34 micromol/L) or liver enzymes > 3 times upper limit of normal.
- Unstable angina pectoris or New York Heart Association Class III or IV congestive heart failure.
- A history of any major medical condition, including but not limited to: aortic aneurysm; myocardial infarction, stroke, or other cardiovascular events in the past 3 months; gastrointestinal bleeding in the past 3 months; HIV; and other medical conditions deemed serious by the investigator. Active Hepatitis B or C (currently active disease defined as an abnormal liver biopsy or persistent, elevated transaminases, SGOT, SGPT).
- Any risk of bleeding, including a history of bleeding diathesis and a platelet count < 100,000/mm³.
- Active or metastatic cancer (note: superficial basal carcinoma of the skin is not an exclusion).
- Anticipated surgery within trial period.
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- History of noncompliance to medical regimens in Keryx Study No.101-301.
- Participation in any experimental drug study in the past 60 days, except for KRX-101-301, prior to entry into the study, or plan to participate in any experimental drug study during the study period.
- Lactation, pregnancy, or an anticipated or planned pregnancy during the study period.
- Known allergy or intolerance to any heparin-like compounds.
- Patients with other specific renal diseases known to be the cause of nephropathy, and patients with other specific, clinically significant renal disease.
- Inability to give an informed consent or cooperate with the study personnel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Tolerability and Safety Study of KRX-101 (Sulodexide Gelcaps) for the Treatment of Type 2 Diabetic Nephropathic Patients With Persistent Microalbuminuria in Australia, New Zealand, and Hong Kong
The purpose of this study is to assess the tolerability and safety of KRX-101 in treating persistent microalbuminuria in type 2 diabetic patients who are also being treated with stable, maximum tolerated doses of either ACE inhibitors or A2 receptor blockers.
Read the detailed description
Diabetes is one of the most common causes of end-stage renal disease (ESRD) in the U.S. and in many other developed nations. Despite advances in clinical care, including improvements in glycemic and blood pressure control, the number of new cases of diabetes-related ESRD continues to rise, especially in patients with type 2 diabetes.
The current standard of care for the prevention and treatment of diabetic renal disease includes screening all diabetic patients for microalbuminuria. Patients who test positive for microalbuminuria are then treated with either ACE inhibitors or A2 receptor blockers. Both of these classes of medication have been shown to reduce levels of microalbuminuria in some patient populations. This improvement in microalbuminuria has also shown a delay of progression to a number of other renal function problems, as well as a minimal delay in certain clinical events including ESRD.
Unfortunately, some patients achieve the majority of their therapeutic effect of ACE inhibitors or A2 receptor blockers within the first 6 months of therapy, and many of these patients continue to show persistent microalbuminuria. Therefore, these patients are at an increased risk of progressing to ESRD due to the lack of adequate benefit from their current medication.
Microalbuminuria has a straight-line relationship with adverse renal outcomes; therefore any level of reduction may have clinical benefit. It is reasonable to believe that patients who can reduce or have a complete remission of their microalbuminuria may also lessen the risk of progressing to ESRD. Thus, if KRX-101 is able to cause a reduction or complete remission of microalbuminuria to normoalbuminuria, patients may receive a significant clinical benefit.
- Conditions
- Diabetic Nephropathy
- Being tested
- sulodexide
- Keywords
- Diabetes, Microalbuminuria, Proteinuria, Albuminuria, KRX-101, Sulodexide, Nephropathy, Keryx, Collaborative Study Group, Diabetic nephropathy with persistent microalbuminuria
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Proteinuria, Albuminuria, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sulodexideDrug
Also called KRX-101
| Study group | Role | What they receive |
|---|---|---|
| Sulodexide | Experimental | Open label extension to original trial Receives: Drug: sulodexide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed ACR level from the first visit to the end of study
Open label safety extension to assess long-term exposure to sulodexide (KRX-101) in patients with albumin and protein in their urine.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: Interim analysis of efficacy trial showed no drug efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keryx Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Collaborative Study Group (CSG)
- Responsible party
- Sponsor
- Investigators
- Robert Atkins, MD, Study director, Monash Medical CentreAnne Reutens, MD, Principal investigator, Monash Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462202
- Sponsor's protocol ID
- KRX 101-302
- Status last verified
- Mar 2017
- First submitted
- 16 Apr 2007
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Tolerability and Safety Study of KRX-101 (Sulodexide Gelcaps) for the Treatment of Type 2 Diabetic Nephropathic Patients With Persistent Microalbuminuria in Australia, New Zealand, and Hong Kong
- ClinicalTrials.gov ID
- NCT00462202
- Acronym / sponsor ID
- KRX 101-302
- Conditions
- Diabetic Nephropathy
- Keywords
- Diabetes, Microalbuminuria, Proteinuria, Albuminuria, KRX-101, Sulodexide, Nephropathy, Keryx
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis of efficacy trial showed no drug efficacy.
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Keryx BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Collaborative Study Group (CSG)
- Study start
- Apr 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 18 Apr 2007 (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 assess the tolerability and safety of KRX-101 in treating persistent microalbuminuria in type 2 diabetic patients who are also being treated with stable, maximum tolerated doses of either ACE inhibitors or A2 receptor blockers.
Detailed description
Diabetes is one of the most common causes of end-stage renal disease (ESRD) in the U.S. and in many other developed nations. Despite advances in clinical care, including improvements in glycemic and blood pressure control, the number of new cases of diabetes-related ESRD continues to rise, especially in patients with type 2 diabetes.
The current standard of care for the prevention and treatment of diabetic renal disease includes screening all diabetic patients for microalbuminuria. Patients who test positive for microalbuminuria are then treated with either ACE inhibitors or A2 receptor blockers. Both of these classes of medication have been shown to reduce levels of microalbuminuria in some patient populations. This improvement in microalbuminuria has also shown a delay of progression to a number of other renal function problems, as well as a minimal delay in certain clinical events including ESRD.
Unfortunately, some patients achieve the majority of their therapeutic effect of ACE inhibitors or A2 receptor blockers within the first 6 months of therapy, and many of these patients continue to show persistent microalbuminuria. Therefore, these patients are at an increased risk of progressing to ESRD due to the lack of adequate benefit from their current medication.
Microalbuminuria has a straight-line relationship with adverse renal outcomes; therefore any level of reduction may have clinical benefit. It is reasonable to believe that patients who can reduce or have a complete remission of their microalbuminuria may also lessen the risk of progressing to ESRD. Thus, if KRX-101 is able to cause a reduction or complete remission of microalbuminuria to normoalbuminuria, patients may receive a significant clinical benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sulodexide | Experimental | Drug: sulodexideOpen label extension to original trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age and has successfully completed Keryx Study 101-301.
- Diagnosis of DM2 based on ADA criteria.
- Continued stable seated systolic blood pressure < 150 mmHg and diastolic blood pressure < 90 mmHg.
- Provide written informed consent to participate in the study.
- If female and of childbearing potential, must continue to be willing to use adequate contraception, as determined by the investigator, for the duration of the study.
Key exclusion criteria (12 listed)
- Evidence of hepatic dysfunction including total bilirubin > 2.0 mg/dL (34 micromol/L) or liver enzymes > 3 times upper limit of normal.
- Unstable angina pectoris or New York Heart Association Class III or IV congestive heart failure.
- A history of any major medical condition, including but not limited to: aortic aneurysm; myocardial infarction, stroke, or other cardiovascular events in the past 3 months; gastrointestinal bleeding in the past 3 months; HIV; and other medical conditions deemed serious by the investigator. Active Hepatitis B or C (currently active disease defined as an abnormal liver biopsy or persistent, elevated transaminases, SGOT, SGPT).
- Any risk of bleeding, including a history of bleeding diathesis and a platelet count < 100,000/mm³.
- Active or metastatic cancer (note: superficial basal carcinoma of the skin is not an exclusion).
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: KRX-101 | Drug | Sulodexide |
Primary outcome
Observed ACR level from the first visit to the end of study
Time frame: 1 year
Open label safety extension to assess long-term exposure to sulodexide (KRX-101) in patients with albumin and protein in their urine.
Results and safety
The study was stopped early (reason given: Interim analysis of efficacy trial showed no drug efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Robert Atkins, MD study director
Monash Medical Centre
Anne Reutens, MD principal investigator
Monash Medical Center
1 site 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 Diabetic Nephropathy, run by Keryx Biopharmaceuticals at 1 site in Australia.
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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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. 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?
The study was stopped early (reason given: Interim analysis of efficacy trial showed no drug efficacy.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed ACR level from the first visit to the end of study (time frame: 1 year). 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 3 Mar 2017.