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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT00672451
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients \>18 years
2. Patients with diabetic nephropathy (history of type 1 or type 2 diabetes for \> 7 years, no other cause for proteinuria listed in their medical chart). This is the definition used in most peer-reviewed trials44,45 of diabetic nephropathy. We do recognize that their proteinuria could be due to some other concomitant kidney disease but the only way to confirm that is to do a kidney biopsy which is not clinically justified.
3. Proteinuria ≥ 0.5 g/day
4. Ability to sign consent form
Exclusion Criteria:
1. Pre study GFR (see section 10.7) \< 20 ml/min
2. Renal disease of etiologies other than diabetes
3. Uncontrolled hypertension (Systolic BP \>180 mmHg and Diastolic BP \>110mm Hg)
4. Patients with history of kidney stones in past 10 years
5. Patients with active chronic liver disease (Liver enzymes ALT, AST \>2.5 times normal)
6. Patients with primary small bowel disease with malabsorption, blind loop syndrome, or jejunoileal bypass surgery (may cause unabsorbed fatty acids to combine with calcium which in turn causes too much absorption of oxalate)
7. Patients with current alcohol, illicit drug use or any other condition (eg. Psychiatry disorder) that in the opinion of the investigator may interfere with the patient's ability to comply with the study
8. Pregnant women or women of child bearing potential who are unwilling to use an adequate form of contraceptive during the course of the study (ACEI may be fetotoxic)
9. Patients with significant unstable cardiovascular disease (NYHA class III and IV)
10. Patients with active malignancy
11. Uncontrolled infections.
12. Patients with a known sensitivity to the study medications (including enalapril)
13. Patients on angiotensin II receptor blockers (ARBs)
14. Microscopic or macroscopic hematuria (to rule out kidney disease other than diabetic nephropathy)
15. Patients on any herbal supplements unwilling to discontinue them
16. Severe malnutrition (serum albumin \<2.6mg/dL)
17. Hyperkalemia at baseline, defined as serum potassium ≥ 5.5 mg/dL
18. Iodine allergy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00672451
Study Brief:
Protocol Section:
NCT00672451