Nitrite, Isoquercetin and Endothelial Dysfunction (NICE) Trial

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The proposed randomized controlled trial will test the safety and efficacy of combination therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among patients with chronic kidney disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jing Chen; Tulane University
• Collaborator: National Institute of General Medical Sciences (NIGMS)

Criteria

Inclusion Criteria:

• Men and women aged 21-74 years old with any race/ethnicity background

• CKD as defined by an eGFR <60 ml/min/1.73 m2 or urinary albumin to creatinine ratio ≥ 30 mg/g or protein to creatinine ratio ≥150 mg/g.

• Systolic BP≥120 and <180 mmHg and/or diastolic BP≥70 and <110 mmHg

Exclusion Criteria:

• Allergic to organic nitrite, isoquercetin, niacin, or vitamin C

• Institutionalized (e.g., prisoner, nursing home or skilled nursing facility resident)

• Unable or unwilling to give consent

• Known HIV infection and/or AIDS

• Pregnant or lactating women

• Currently on dialysis

• Previous or current organ or bone marrow transplant

• Receiving immunosuppressive treatment or other immunotherapy

• Receiving chemotherapy or alkylating agents for systemic cancer

• Recent acute myocardial infarction, cerebrovascular accidence or transient ischemic attack, or hospitalization in 3 months

• Acute kidney injury within the previous 3 months

• Currently taking a phosphodiesterase-5 enzyme inhibitor, such as Viagra

• History of chronic headaches

• Chronically receiving fluoroguinolones, cyclosporin (neural, sandimmune), nitrate drug, NSAIDS ( except aspirin ≤ 81 mg daily), allopurinol or uloric, meperidine and related central nervous system (CNS) depressants, oral glucocorticoids, and not willing or able to stop during study period.

• Active infection (i.e. systemic or osteomyelitis)

• Class III or IV heart failure

• History of hemolytic anemia including sickle cell disease

• Hemoglobin <10

• History of chronic obstructive pulmonary disease (COPD)

• Have a positive screen for glucose-6-phosphate dehydrogenase (G6PD) deficiency at screening

• Involvement in other clinical trials

• Current alcohol or other substance abuse

• Current smokers

• Unwillingness to stop flavonoid supplementation

• Unwillingness to stop nitrate and/or nitrite supplementation