Status:
COMPLETED
Phosphate Lowering in CKD Trial
Lead Sponsor:
VA Office of Research and Development
Conditions:
Chronic Kidney Disease
Cardiovascular Disease
Eligibility:
All Genders
40-79 years
Phase:
PHASE4
Brief 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...
Detailed Description
Chronic kidney disease (CKD) is a major health concern both in the general and Veteran populations. Indeed, the prevalence of CKD in a large Veteran population is 20%. Cardiovascular disease (CVD) is ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2019
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT02209636
Start Date
September 15 2014
End Date
December 20 2019
Last Update
August 26 2022
Active Locations (1)
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1
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045