Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT00462202
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00462202
Study Brief:
Protocol Section:
NCT00462202