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:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT00231803
Eligibility Criteria:
Inclusion Criteria:
* Stratum 1 (expected about 50% of trial subjects): Diabetes mellitus (by clinical history with documented prior plasma glucose levels in the diabetic range, or on hypoglycemic medications) and CKD as documented by calculated (Cockroft-Gault equation) creatinine clearance between 25 and 60 mls/min/1.73m2 derived from the screening serum creatinine value and the next most recent known value from more than 2 weeks prior; OR
Stratum 2 (expected about 20% of trial subjects): Non-diabetic with CKD as defined for Stratum 1 and proteinuria of \> 1g/L by dipstick in random urine at screening; OR
Stratum 3 (expected about 30% of trial subjects): Non-diabetic with CKD as defined for stratum 1, but without proteinuria as for stratum 2 at screening
Exclusion Criteria:
* Unwilling to provide informed consent
* Likely to die of any known existing disease within 6 months
* Recently unstable/advanced cardiovascular disease (MI or acute coronary syndrome, hospitalized heart failure, TIA or stroke, leg amputation or gangrene in past 6 months)
* Currently receiving active treatment for a malignant, neoplastic disease other than localized non-melanoma skin cancer
* Progressive kidney disease currently treated by immunotherapy
* Currently receiving dialysis or likely to do so within 6 months
* Current organ transplant recipient (or planned within 6 months)
* Currently receiving ongoing care for CKD, or cardiovascular disease, in a multiple intervention, disease management program.
* Currently enrolled in another interventional trial
* Residing in a location not amenable to follow up for the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00231803
Study Brief:
Protocol Section:
NCT00231803