Phase 4
N=61
Phosphate Lowering in CKD Trial
Chronic Kidney Disease · Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT02209636 ↗Enrolled (actual)
61
Serious AEs
5.3%
Results posted
Aug 2022
Primary outcome: Primary: Brachial Artery Flow-mediated Dilation — 3.13; 3.74; 2.73; 3.09 percent change FMD
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lanthanum carbonate (Drug); placebo (Drug); Ascorbic Acid (Drug); Nitroglycerin (Drug); Flow-mediated dilation measurement (Procedure); Aortic pulse-wave velocity (Procedure); Endothelial cell collection (Procedure)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brachial Artery Flow-mediated Dilation |
3.13; 3.74; 2.73; 3.09 | — |
| PRIMARY Aortic Pulse-wave Velocity |
1214; 993; 1216; 977 | — |
| PRIMARY Phosphorus Balance Sub-study (COMIRB 15-0384) |
-131; 320 | — |
| SECONDARY Oxidative Stress-associated Suppression of EDD |
2.91; 3.54; 3.24; 3.44; 2.48; 2.95 | — |
| SECONDARY Vascular Endothelial Cell Protein Expression |
1.54; 1.41; 1.44; 1.40 | — |
| SECONDARY Interleukin-6 to Measure Systemic Inflammation |
1.58; 1.28; 1.61; 1.34 | — |
| SECONDARY Oxidized Low-density Lipoprotein (Ox-LDL) to Measure Systemic Oxidized Stress |
61837; 62927; 59725; 68057 | — |
| SECONDARY C-reactive Protein to Measure Systemic Inflammation |
2.92; 2.72; 3.06; 2.24 | — |
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
Data sourced from ClinicalTrials.gov (NCT02209636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.