Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multi-Center Study of the Effect of Sevelamer Carbonate (Renvela®) on Metabolic/Inflammatory/ROS in Diabetics With Nephropathy
Brief Summary: The purpose of this study is to see if taking a medication can lower the amount of oxidants from food that go into our body. Previous research shows that if the investigators lower the oxidants from food in people with diabetes, this simple change lowers different risks for heart disease and the worsening of kidney disease. The investigators focus on a specific type of oxidant, advanced glycation endproducts (AGEs). A previous, smaller study, conducted by our group showed that a drug, already approved by the FDA, will lower AGEs in the investigators compared Renvela® to Tums®. Both of these drugs have few side effects and have been used for a long time in patients with diabetes and kidney disease. While our previous study was interesting, it was just too small to be able to be sure that it will help all people with diabetes, or if the good effects the investigators found were simply due to chance. The investigators are doing this new study to confirm or deny the possibility that Renvela® can really help people with diabetes and kidney disease.


Options:
A: Inclusion Criteria:

* Stage III to V Chronic Kidney Disease
* Serum Phosphorus 4.0-6.0 mg/dL prior to Randomization
* Ferritin 300 ng/mL or less
* Transferrin Saturation (TSAT) 30% or less
* Hemoglobin \>9.0 and \<12.0 g/dL
* Must consume a minimum of 2 meals per day

Exclusion Criteria:

* Parathyroidectomy within 24 weeks of study
* gastrointestinal bleed or inflammatory bowel disease within 12 weeks of study
* Requirement for dialysis or kidney injury within 8 weeks of study
* Absolute requirement for oral iron, intravenous iron, Erythropoiesis-Stimulating Agent, blood transfusions, and Sensipar during the study
* Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
* Absolute requirement for vitamin C, niacin, or nicotinamide outside of multivitamins
* History of hemochromatosis
* Allergy to iron products
* History of malignancy in last 5 years
B: Inclusion Criteria:

* Age \> 18 years
* Evidence of CKD Stages II, III or IV
* Stage II CKD; eGFR 60-89 ml/min
* Stage III CKD: eGFR 30-59 ml/min
* Stage IV CKD: eGFR 15-29 ml/min
* Proteinuria (\>200 mg/day or 300 mg/gm creatinine on a spot urine) on urinalysis on two occasions within 18 months of recruitment
* Diagnosis of diabetes and receiving at least one medication for diabetes mellitus
* HbA1c\>6.5%

Exclusion criteria:

* Age \<18
* Patients receiving active treatment for hyperphosphatemia
* Biopsy proven renal disease other than diabetic nephropathy
* Hypophosphatemia
* Hypercalcemia
* Any history of significant gastrointestinal disorders
* Any history of significant gastrointestinal surgery such as ileostomy, colostomy and colectomy.
C: Inclusion Criteria:

* Men or women greater than 18 years of age.
* The subject has voluntarily signed and dated the most recent informed consent form approved by an Institutional Review Board (IRB).

Exclusion Criteria:

* Receiving hemodialysis.
* Receiving or has received an investigational product (or is currently using an investigational device) within 28 days prior to Visit 2.
* Evidence of active and clinically significant infection at Visit 2.
* Dental work within 48 hours prior to Visit 2.
D: Inclusion Criteria:

* age \>18 years,
* CKD stage 3-5

Exclusion Criteria:

* Existing or previous treatment within the last 1 year with a phosphate binder;
* hyperphosphatemia (\>5.6 mg/dL);
* hypophosphatemia (\<2.5 mg/dL);
* malnutrition,
* malignant neoplasms,
* current history of gastrointestinal and/or endocrine diseases.

Answer: B