Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China

Exclusion Criteria

• •Men or women below 18 years of age.
• •Any technical/administrative reason that made it impossible to randomize the participant in the study.
• •Was 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 safety reasons.
• •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.
• •Had participated in any other investigational drug studies within 30 days, or 5 half lives, whichever is longer, prior to screening visit.
• •Conditions/situations such as:
• •* Participant was the Investigator or any Subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
• •* Uncooperative or any condition that could make the participant potentially non-compliant to the study procedures (for example, participants could not be contacted by phones as required in phone call visits).
• •* Evidence of active malignancy.
• •* Not on stable medical condition (for example, but not limited to, active ethanol or drug abuse \[tobacco use acceptable\]; documented poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus \[HIV\] infection), or had any clinically significant medical conditions.
• •Had known hypersensitivity to sevelamer or any constituents of Renvela tablets.
• •Had 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 seizure disorders.
• •Was pregnant or breast-feeding.
• •If the participant was female, and of childbearing potential (pre-menopausal and not surgically sterile), was not willing to use an effective contraceptive method throughout the study.
• •Had any condition, which in the opinion of the investigator would prohibit the participant's inclusion in the study.
• •The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.