Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
Brief Summary: Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of vitamin B, to reduce phosphate uptake by the rat small intestine. Our trial investigates the use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma phosphorus levels in peritoneal dialysis patients versus placebo.


Options:
A: Inclusion criteria:

1. Men or women of at least 18 years of age
2. Stable maintenance of hemodialysis 3 times per week for 3 months or greater
3. Controlled serum phosphate if under phosphate-binder therapy
4. Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening

Exclusion criteria:

1. Patients who are on peritoneal dialysis
2. Patients who have a transplant or parathyroidectomy scheduled during the study
3. Clinically significant GI disorder
4. Unstable medical condition other than Chronic Kidney Disease
5. Patient is currently being treated with oral iron
6. History of hemachromatosis, or ferritin \> 1000 ng/mL
7. Transferrin saturation \> 60%
8. Uncontrolled hyperparathyroidism (iPTH \> 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply
B: Inclusion Criteria:

* Age \> 18 years
* Capable of giving informed consent
* Duration of peritoneal dialysis \> 3 months
* Dose of phosphate binder(s) stable over previous 2 week period
* Plasma phosphours \> 4.9 mg/dL based on most recent laboratory data within 1 month of enrollment

Exclusion Criteria:

* Pregnancy
* Known liver disease
* Active peptic ulcer disease
* Treatment with carbamazepine
* Intolerance to niacinamide or niacin
* Current medication regimen including niacin or niacinamide \> 100 mg daily
* Planned or expected surgical procedure in the next 4 months
* Patients in nursing home or extended care facilities where administration of the study drug may not be appropriately given
C: Inclusion Criteria:

* life expectancy of at least 12 months,
* patients have received hemodialysis three times per week for 3 months or longer,
* patients maintained on sevelamer in a daily dose of ≤ 9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL (0.97 and 2.10 mmol/L).

Exclusion Criteria:

* active bowel obstruction,
* dysphagia,
* swallowing disorders,
* severe gastrointestinal motility disorders,
* active ethanol or drug abuse (excluding tobacco),
* need for antidysrhythmic or antiseizure medications used to control these conditions,
* poorly controlled diabetes mellitus or hypertension,
* active vasculitis,
* active malignancy other than basal-cell carcinoma,
* HIV infection,
* any clinically significant unstable medical condition as judged by the investigator.
D: Inclusion Criteria:

* We will include stage 3a, 3b and 4 CKD patients, aged 18 years or over with normal serum phosphate levels (≤ 4.6 mg/dl)

Exclusion Criteria:

* Patients with rapidly advancing renal failure who thus might develop hyperphosphatemia or end stage renal disease requiring initiation of dialysis during the study period
* Patients expected to require dialysis initiation within the follow up period
* Patients with hyperphosphatemia \> 4.6 mg/dl
* Patients with any previous or current treatment with phosphate binders or active vitamin D (doxercalciferol or calcitriol)
* Malnutrition, defined as a serum albumin \< 3.0 mg/dl
* Patients with liver disease (ALT or AST \> 100 U/L) or cholestasis (direct bilirubin \> 1.0 mg/dl) because this can limit their ability to absorb fat soluble vitamins such as vitamin D
* Anemia, defined as a hematocrit \< 27% at the screening visit
* Medical conditions impacting Pi metabolism-primary hyper- or hypoparathyroidism; Patients with previous subtotal parathyroidectomy; gastrointestinal malabsorption disorders such as Crohn's Disease, ulcerative colitis, celiac disease, or severe liver dysfunction;
* Patients with outpatient counseling by a renal nutritionist within the previous 6 months
* Hospitalization within the previous 4 weeks
* Pregnancy or breastfeeding mothers
* Patients unable to independently provide written informed consent - prisoners, mentally incompetent, minors

Answer: B