Status:
TERMINATED
Open Label Tolerability and Safety Study of KRX-101 in Australia, New Zealand, and Hong Kong
Lead Sponsor:
Keryx Biopharmaceuticals
Collaborating Sponsors:
Collaborative Study Group (CSG)
Conditions:
Diabetic Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 tolera...
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 b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00462202
Start Date
April 1 2007
End Date
March 1 2008
Last Update
March 3 2017
Active Locations (1)
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1
Monash Medical Center
Melbourne, Victoria, Australia, 3168