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An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients | Clinical Trials | Clareo Health

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An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients

An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic Chronic Kidney Disease Patients

NCT02332811•Genzyme, a Sanofi Company

View on ClinicalTrials.gov

Summary

Primary Objective: Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis Secondary Objective: Evaluate the safety on the basis of adverse events, changes in laboratory values and vital signs from baseline (Day 0) to Day 56 (End of treatment/ End of Study)

Detailed Description

10 weeks including, 2 weeks wash-out period and 8 weeks study treatment period

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men or women 18 years of age or older suffering from CKD not on dialysis or on a stable haemodialysis regimen
•If currently on phosphate binder(s), willing to stop this and enter a 2 week washout period
•Willing to avoid any intentional changes in diet such as fasting or dieting
•Have the following laboratory measurement:
•* iPTH ≤ 1000 pg/mL at screening (including results obtained within 60 days prior to screening)
•* If not taking a phosphate binder, a serum phosphorus measurement \>5.5 mg/dL (1.78 mmol/L) at Screening (Visit 1).
•* If taking a phosphate binder at screening, a serum phosphorus measurement \> 5.5 mg/dL (1.78 mmol/L) after the two-weeks washout period at Visit 1a (Day 0).
•Willing and able to take Sevelamer carbonate alone as a phosphate binder for the duration of the study
•Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study
•Willing and able to maintain screening doses of vitamin D, and/or cinacalcet for the duration of the study, except for safety reasons
+5 more criteria

Exclusion Criteria

•Active dysphagia or swallowing disorder
•Predisposition or current bowel obstruction,
•Severe gastrointestinal (GI) motility disorders including severe constipation
•Active ethanol or drug abuse, excluding tobacco use
•Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
•In the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
•Planned renal transplant or parathyroidectomy within 3 months of Visit 1
•Pregnant or breast-feeding
•Evidence of active malignancy except for basal cell carcinoma of the skin
•Unable to comply with the requirements of the study
+3 more criteria

Locations (1)

Russia

Moscow, Russia

Key Dates

Start Date

October 1, 2013

Primary Completion Date

July 1, 2014

Completion Date

July 1, 2014

Last Updated

December 23, 2016

Enrollment

ACTUAL participants

Conditions

Renal Failure Chronic

Interventions

sevelamer carbonate 800mg

DRUG

sevelamer carbonate 2.4 g

DRUG

The Outcomes of Living Donor Robotic Assisted Kidney Transplantation

NCT06577805

Kidney Transplant; ComplicationsRenal Failure Chronic

View study

ACTIVE_NOT_RECRUITINGNA

SelfWrap-Assisted Arteriovenous Fistulas

NCT05418816

Chronic Kidney DiseasesChronic Kidney Failure+15 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients

Inclusion Criteria

Exclusion Criteria

The Outcomes of Living Donor Robotic Assisted Kidney Transplantation

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Immunotherapy of Chronic Kidney Failure

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