Open Label Tolerability and Safety Study of KRX-101 in Australia, New Zealand, and Hong Kong

• Status: Terminated
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Keryx Biopharmaceuticals
• Collaborator: Collaborative Study Group (CSG)
• Treatments: Glucuronyl glucosamine glycan sulfate

Criteria

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.