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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT03597035
Eligibility Criteria:
Inclusion Criteria
1. Male or female patients \>= 45 years and able to provide informed consent (females must be either post-menopausal for one year, surgically sterile, or using effective contraception. Oral contraceptives are disallowed.)
2. Patients with type II diabetes with HbA1c ≤ 9.0 on stable anti-glycemic regimen that may include oral and/or injectable therapy (GLP-1/Insulin etc.). Changes in dose of glycemic regimen is allowed during the course of the trial if felt to be clinically appropriate.
3. Glomerular filtration rate (GFR) \<90 and evidence of proteinuria (Urine Albumin/Creatinine Ratio of \>30 mg/g or equivalent) in a urine specimen within 12 months OR GFR \<60 mg/g regardless of proteinuria
4. Patients must be on angiotensin-converting-enzyme inhibitor (ACE) and/or angiotensin-resistance-blocker (ARB) therapy with no planned dose adjustments.
5. Hyperkalemia defined as serum K+≥ 5.1 meq/L at visit 0 (screening).
Exclusion Criteria
1. Uncontrolled hypertension (Systolic Blood Pressure (SBP)\>160 and/or Diastolic Blood Pressure (DBP)\>95 mmHg at visit 0 (screening) and SBP \>145 mm Hg at visit 2).
2. GFR (MDRD) of \<20 at visit 0 (screening)
3. Hyperkalemia defined as serum K+ \<5.1 meq/L at visit 0 (screening).
4. LDL cholesterol \>150 mg/dL
5. Plasma triglycerides \> 400 mg/dl
6. Contraindications to MRI (metallic implants, severe claustrophobia).
7. Acute coronary syndrome, Transient ischemic attack, cardiovascular accident (CVA) or critical limb ischemia during the last 6 months or coronary/peripheral revascularization within the last 3 months.
8. Evidence of a secondary form of hypertension.
9. Initiation of new therapy with statins, ACE/ARB, antioxidants, calcium channel blockers (CCBs), diuretics, β blockers.
10. Type I diabetes mellitus
11. Known contraindication, including history of allergy to Spironolactone or Patiromer
12. Any surgical or medical condition which might alter pharmacokinetics of drug (e.g. renal transplant, liver failure, liver transplant)
13. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
14. Significant hyponatremia defined as Na \<130 meq/L.
15. History of prior malignancy including leukemia and lymphoma (but not basal cell skin cancer, cured squamous cell cancer and cured prostate cancer).
16. History of any severe, life-threatening disease.
17. Any surgical or medical conditions which place the patient at higher risk derived from his/her participation into the study, or likely to prevent patient from complying with requirements.
18. History of drug abuse within the last 2 years, noncompliance and unwillingness/inability to consent.
19. Pregnant women and nursing mothers
20. Class III or IV Congestive Heart Failure
21. Primary Hyperaldosteronism
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT03597035
Study Brief:
Protocol Section:
NCT03597035