The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE (COMBINE)
Chronic Kidney Disease
About this trial
This is an interventional other trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- Patients with estimated glomerular filtration rate (eGFR) 20-45 ml/min/1.73m2
- Age 18-85 years
- Serum phosphate ≥ 2.8 mg/dL
- Platelet count ≥ 125,000/mm3
- Able to provide consent
- Able to travel to study visits
- Able to eat at least two meals a day
- In the opinion of the site investigator, willing and able to follow the study treatment regimen and comply with the site investigator's recommendations.
Exclusion Criteria:
- History of allergic reaction to nicotinamide, niacin (excluding flushing), multivitamin preparations, or lanthanum carbonate
- Liver disease, defined as known cirrhosis by imaging or physician diagnosis, documented alcohol use > 14 drinks/week, or aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or total bilirubin concentrations > 2 times the upper limit of the local laboratory reference range
- Creatine kinase (CK) concentrations > 2 times the upper limit of the local laboratory reference range
- Major hemorrhagic event within the past six months requiring in-patient admission
- Blood or platelet transfusion within the past six months
- Secondary hyperparathyroidism (PTH > 5 times the upper limit of normal range for the laboratory) or currently taking cinacalcet (Sensipar)
- Current, clinically significant malabsorption, as determined at the discretion of the site investigator
- Anemia (screening Hg < 9.0 g/dl)
- Serum albumin < 2.5 mg/dl
- Anticipated initiation of dialysis or kidney transplantation within 12 months as assessed by and at the discretion of the site investigator.
- Use of immunosuppressive medications (stable oral steroids ≤ 10 mg of prednisone/day or inhaled steroids are exempted)
- In the opinion of the site investigator, active abuse of alcohol or drugs
- Recent (within the last 14 days) initiation or change in dose of treatment with 1,25 (OH)2 vitamin D or active vitamin D analogues (paricalcitol or hectorol). Patients on stable doses of these agents initiated more than 14 days prior to screening are eligible to participate.
- Current or recent treatment (within the last 14 days) with phosphate binder or niacin/nicotinamide > 100 mg/day
- Current participation in another clinical trial or other interventional research
- Currently taking investigational drugs
- Institutionalized individuals, including prisoners and nursing home residents
Malignancy requiring therapy within 2 years (basal or squamous cell skin carcinoma and localized prostate cancer are exempted)
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Sites / Locations
- University of California at San Diego
- Denver Nephrology Research
- George Washington University
- NorthShore University Health System
- Northwestern University
- University of Utah
- Utah VA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Active Comparator
Placebo Comparator
Lanthanum carbonate + nicotinamide
Lanthanum carbonate + nicotinamide placebo
Lanthanum carbonate placebo and nicotinamide
Lanthanum carbonate placebo and nicotinamide placebo
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months. One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months.
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.