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

NCT02332811 | Completed Phase 3

• 2 other identifiers: SVCARB10012U1111-1160-6394
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Renal Failure Chronic

Outcome Measures

Primary Outcomes (1)

• 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

  up to 8 weeks

Study Arms (4)

CKD patients not on dialysis 800 mg

EXPERIMENTAL

Sevelamer carbonate 800 mg in tabs 3 times per day with meals

Drug: sevelamer carbonate 800mg

CKD patients not on dialysis 2.4 g

EXPERIMENTAL

Sevelamer carbonate 2.4 g powder carbonate per day

Drug: sevelamer carbonate 2.4 g

CKD patients on dialysis 800 mg

EXPERIMENTAL

Sevelamer carbonate 800 mg in tabs 3 times per day with meals

Drug: sevelamer carbonate 800mg

CKD patients on dialysis 2.4 g

EXPERIMENTAL

Sevelamer carbonate 2.4 g powder carbonate per day

Drug: sevelamer carbonate 2.4 g

Interventions

sevelamer carbonate 800mg DRUG

Pharmaceutical form:tablet Route of administration: oral

Also known as: Renvela

CKD patients not on dialysis 800 mg; CKD patients on dialysis 800 mg

sevelamer carbonate 2.4 g DRUG

Pharmaceutical form:powder Route of administration: oral

Also known as: Renvela

CKD patients not on dialysis 2.4 g; CKD patients on dialysis 2.4 g

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• If female and childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or intrauterine devices
• For patients not on dialysis expecting not to initiate dialysis for the duration of this study
• Signed informed consent
• Has not participated in any other investigational drug studies within 30 days prior to enrollment
• Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel

You may not qualify if:

• 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
• Known hypersensitivity to sevelamer or any constituents of the study drug
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (1)

Russia

Moscow, Russia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Sevelamer

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: January 7, 2015
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 23, 2016

Record last verified: 2016-12

Locations

RU (1)