Open Label Tolerability and Safety Study of KRX-101 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.

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

Conditions

Diabetic Nephropathy

Study Type

Interventional

Study Design

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Further Details

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 end-stage renal disease (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.

• Primary Outcome Measures: Observed ACR level from the first visit to the end of study.
• Secondary Outcome Measures: Safety evaluations including review of adverse events and lab parameters from first visit to end of study.
• More information about KRX-101

Study Start

April 2007

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• 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 Criteria:

• 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.

Total Enrolment

200

Contact Details

Monash Medical Center, Melbourne, Victoria, 3168, Australia; Recruiting

• Anne Reutens, MD; +61 3 9258 5043, Anne.Reutens@med.monash.edu.au
• Michelle Sharp; +61 3 8317 5300, msharp@tridentcr.com

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