Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients

NCT00267514 | Completed Phase 3

• 1 other identifier: SVCARB00205
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine if sevelamer carbonate powder is an effective treatment for the control of serum phosphorous levels in patients on dialysis when compared to sevelamer hydrochloride tablets.

Conditions

Chronic Kidney Disease

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (2)

• Demonstrate the equivalence of sevelamer carbonate powder to sevelamer hydrochloride tablets dosed three times per day (TID) with meals on the control of serum phosphorus levels

  Up to 13 weeks

• Evaluate the safety and tolerability of sevelamer carbonate powder compared to sevelamer hydrochloride tablets dosed TID with meals

  Up to 13 weeks

Secondary Outcomes (2)

• Compare the effects of sevelamer carbonate powder to sevelamer hydrochloride tablets when dosed three times a day with meals on: serum calcium-phosphorus product

  Up to 13 weeks

• serum lipid profile (total cholesterol, high density lipoprotein [HDL] and low density lipoprotein [LDL] and triglycerides)

  Up to 13 weeks

Study Arms (2)

1

OTHER

sevelamer carbonate powder x 4 weeks then, sevelamer hydrochloride x 4 weeks

Drug: sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)

2

OTHER

sevelamer hydrochloride x 4 weeks then, sevelamer carbonate powder x 4 weeks

Drug: sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)

Interventions

sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®) DRUG

sevelamer carbonate powder dosed TID with meals for four weeks followed by sevelamer hydrochloride tablets dosed TID with meals for four weeks

1

sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®) DRUG

sevelamer hydrochloride tablets dosed TID with meals for four weeks followed by sevelamer carbonate powder dosed TID with meals for four weeks

2

Eligibility Criteria

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

You may qualify if:

• Receiving three times per week haemodialysis for three months or longer.
• Taking sevelamer hydrochloride alone (e.g. not using other types of phosphate binders concomitantly) or on combination therapy (e.g. using sevelamer hydrochloride and calcium containing, or metal phosphate binders concomitantly) not exceeding a total daily binder dose of 14.4 g, for at least 60 days prior to screening.
• Have the following documented local laboratory measurements:
• Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 7.0 mg/dL (≥ 0.96 and ≤ 2.26 mmol/L) within 60 days of screening
• An most recent iPTH measurement ≤ 900 pg/mL (\< 99 pmol/L) within 90 days of screening
• A most recent serum calcium (adjusted for albumin) measurement within normal range defined by the local laboratory within 60 days of screening
• Have the following central laboratory measurements:
• A serum phosphorus measurement ≥ 5.5 mg/dL (≥ 1.76 mmol/L) at Visit 2 (after Washout)
• A serum iPTH measurement ≤ 800 pg/mL at Visit 5 (prior to randomization)
• A serum phosphorus measurement ≥ 3.0 and ≤ 6.5 mg/dL (≥ 0.96 and ≤ 2.08 mmol/L) at Visit 5
• If on vitamin D replacement or calcimimetics therapy, be at a stable dose for at least one month prior to screening and willing to maintain the same dose throughout the duration of the study, except for safety reasons.
• Willing to maintain screening doses of lipid medication for the duration of the study, except for safety reasons.
• Willing to avoid any intentional changes in diet such as fasting or dieting.
• If female and of 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 (IUDs).
• Willing to stop all calcium supplements not prescribed by the investigator including multivitamins containing calcium.

You may not qualify if:

• Have poorly controlled diabetes mellitus or hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition (defined by investigator).
• Have active dysphagia, swallowing disorders, bowel obstruction, or severe gastrointestinal motility disorders.
• Have participated in a study of an investigational drug during the 30 days preceding the start of the screening period.
• Has active ethanol or drug dependence or abuse, excluding tobacco use.
• Have any other condition, which, in the investigator's opinion, will prohibit the patient's participation in the study.
• If female, be pregnant or breast-feeding.
• Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
• Have a known hypersensitivity to sevelamer or any of its constituents.
• Have a poor record of compliance with medication.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (7)

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

Addenbrooks NHS Trust

Cambridge, CB2 2QQ, United Kingdom

Location

The Royal London Hospital

London, E1 1BB, United Kingdom

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

Hope Hospital

Manchester, M6 8HD, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

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

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2005
• First Posted: December 21, 2005
• Study Start: January 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: May 1, 2007
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

GB (7)