Phosphate Lowering in CKD Trial
Condition: Chronic Kidney Disease; Cardiovascular Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Cardiovascular Diseases
Intervention: Lanthanum carbonate; placebo; Ascorbic Acid; Nitroglycerin; Flow-mediated dilation measurement; Aortic pulse-wave velocity; Endothelial cell collection
Intervention description: Non-calcium containing phosphorus binder; Table identical to lanthanum carbonate but with no active ingredient; Intravenous administration during measurement of flow mediated dilation.; Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.; Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.; Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.; Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
Intervention MeSH terms: Ascorbic Acid; Nitroglycerin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 40 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: hyperphosphatemia; vascular dysfunction; chronic kidney disease; cardiovascular disease; endothelial dysfunction

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]
    

Eligibility 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