Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China
Condition: Hyperphosphatemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Intervention: Placebo; Sevelamer Carbonate (GZ419831)
Intervention description: Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral
Intervention MeSH terms: Sevelamer
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate efficacy of Renvela tablets in the reduction of serum phosphorus in
      hyperphosphatemia in participants with chronic kidney disease not on dialysis.

      Secondary Objectives:

      To document the efficacy of Renvela tablets in the reduction of serum lipids (total
      cholesterol and low-density lipoprotein cholesterol [LDL-C]).

      To document the efficacy of Renvela tablets in the reduction of calcium-phosphorus product.

      To document the efficacy of Renvela tablets in the reduction of intact parathyroid hormone
      (iPTH).

      To document the efficacy of Renvela tablets in proportion of participants reaching the target
      serum phosphorus level 4.6 milligrams per decilitre (mg/dL) (1.47 millimoles per litre
      [mmol/L], inclusive).

      To evaluate safety of Renvela tablets.
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants with chronic kidney disease who had not been on dialysis, and were not
             expected to begin dialysis, or renal transplantation in the next 4 months from the
             screening visit.

          -  Had serum phosphorus measurement greater than or equal to (>=) 5.5 mg/dL (1.78 mmol/L)
             at screening visit (if participants were not on phosphate binder[s] at Screening
             Visit) OR at the end of Washout Period (if participants were on phosphate binder[s] at
             screening visit).

          -  Had the following laboratory measurements at screening visit:

               -  25-hydroxy vitamin D >=10 nanograms per milliliter (ng/mL).

               -  intact parathyroid hormone, intact parathyroid hormone (iPTH) <=800 picograms per
                  millilitre (pg/mL).

               -  Signed written informed consent.

        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.