- Patients with chronic kidney disease who have not been on dialysis, and are not
expected to begin dialysis, or renal transplantation in the next 4 months from the
- Have serum phosphorus measurement â‰¥5.5 mg/dL (1.78 mmol/L) at Screening Visit (if
patients are not on phosphate binder[s] at Screening Visit) OR at the end of Washout
Period (if patients are on phosphate binder[s] at Screening Visit).
- Have the following laboratory measurements at Screening Visit:
- 25-hydroxy vitamin D â‰¥10 ng/mL.
- iPTH â‰¤800 pg/mL.
- Willing and able to sign written informed consent.
- Men or women below 18 years of age.
- Is not of the level of understanding and willingness to cooperate with all visits and
procedures, as described in the study protocol.
- Not yet received chronic kidney disease diet education before screening visit.
- Not willing and not able to avoid changes to diet during the study.
- Not willing or able to maintain screening doses of lipid lowering medication, 1, 25
dihydroxy vitamin D, and/or cinacalcet for the duration of the study, except for
- Not willing or not able to avoid antacids and phosphate binders containing aluminium,
magnesium, calcium, or lanthanum for the duration of the study unless prescribed as an
evening calcium supplement.
- Have participated in any other investigational drug studies within 30 days, or 5 half
lives, whichever is longer, prior to screening visit.
- Have known hypersensitivity to sevelamer or any constituents of Renvela tablets.
- Have bowel obstruction, active dysphagia or swallowing disorder, or a predisposition
to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders
including severe constipation.
- Using or plan to use anti-arrhythmic or anti-seizure medications for arrhythmia or
- Is pregnant or breast-feeding.
- If the patient is female, and of childbearing potential (pre-menopausal and not
surgically sterile), is not willing to use an effective contraceptive method
throughout the study.
- Have any condition, which in the opinion of the investigator would prohibit the
patient's inclusion in the study.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.