Phophate Lowering Trial

• Status: Active, not recruiting
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The proposed research is a randomized-controlled trial to determine the effectiveness of reducing serum phosphorus using a phosphate binder, lanthanum carbonate, for improving the function of arteries in adults with moderate to severe chronic kidney disease (CKD). [COMIRB 13-0328] Additionally, it will determine phosphorus balance among adults with CKD and whether there is a difference in phosphorus balance after three months of treatment with lanthanum carbonate. [COMIRB 15-0384]

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Ascorbic Acid; Nitroglycerin

Criteria

Inclusion Criteria:

• Age 40-79, women must be post-menopausal

• CKD stage IIIb or IV (estimated glomerular filtration rate by MDRD 15-45 mL/min/1.73m2), stable for 3 months

• Serum phosphorus 2.8-5.5 mg/dL, stable for 3 months

• Not using phosphate binders

• Albumin > 3.0 g/dL

• Free from alcohol dependence or abuse

• Ability to provide informed consent

• BMI < 40 kg/m2

• Not taking medications that interact with agents administered during experimental sessions (e.g., sildenafil interacts with nitroglycerin)

• For COMIRB 15-0384, completion of the prospective, randomized, placebo-controlled double-blind trial, Phosphorus Lowering to Treat Vascular Dysfunction in Chronic Kidney Disease (COMIRB 13-0328) or completion of 12-week run-in phase

Exclusion Criteria:

• Life expectancy <1 year

• Uncontrolled hypertension

• History of severe liver disease

• History of congestive heart failure (EF < 35%)

• History of hospitalizations within the last 3 months

• History of ileus or bowel obstruction

• Active infection or antibiotic therapy

• Expected kidney transplant in the next 6 months

• Active vitamin D analogue use (i.e. calcitriol, paricalcitol, doxercalciferol)

• Vasculitis requiring immunosuppressive therapy within the last year

• Current tobacco abuse