Peritoneal DialysisPhase 3NCT00196755
Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis
A Phase 3 study testing Sevelamer Hydrochloride (Renagel®) and Calcium acetate (PhosLo® ) in people with Peritoneal Dialysis and Chronic Kidney Disease, run by Genzyme, a Sanofi Company at 17 sites in 7 countries.
Trial summary
The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis, Chronic Kidney Disease
- What is being tested?
- Sevelamer Hydrochloride (Renagel®) and Calcium acetate (PhosLo® )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 17 sitesin 7 countries
- Study dates
- Dec 2004to Apr 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to sign an informed consent form.
- Men or women aged 18 years of age or older.
- A diagnosis of Chronic Kidney Disease (CKD) and receiving peritoneal dialysis (Continuous cyclical peritoneal dialysis (CAPD), Automated peritoneal dialysis (APD) or Continuous cyclical peritoneal dialysis (CCPD) for 8 weeks or longer.
- In the opinion of the investigator, expected to receive peritoneal dialysis for the duration of the study.
- Will have a serum phosphorus level >1.76 mmol/L(5.50 mg/dL) after 2 weeks washout from their usual phosphate binder.
- Will have serum calcium measurement adjusted for albumin within the range (2.10-2.60 mmol/L (8.40-10.40 mg/dL) following 2 weeks washout from their usual phosphate binder.
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- Willing to maintain the prescribed sevelamer or calcium acetate for the duration of the study.
- Considered compliant with phosphate binders and dialysis.
- On a stable doses of medication to treat hyperparathyroidism (Vitamin D or its analogues or calcimimetic agents) for the month prior to screening.
- Willing to discontinue use of antacids containing calcium, aluminium or magnesium at screening visit for the duration of the study (unless taken as an evening calcium supplement as prescribed by the investigator per protocol).
- Willing to avoid 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).
- Have a level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel.
Who cannot join
- Patients with a history of peritonitis in the last 30 days or > 2 episodes in the last 12 months
- Patient with active dysphagia, swallowing disorder, bowel obstruction, or severe gastrointestinal motility disorder.
- Patients who in the opinion of the investigator have poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, Human Immunodeficiency Virus (HIV) infection, or any clinically significant, unstable medical condition.
- Patients with any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not exclusion.
- Current use of an antiarrhythmic medication such as quinidine, procainamide, tocainide, or amiodarone for the control of arrhythmias.
- Current use of a seizure medication such as phenytoin, phenobarbital, valproate, or carbamazepine for the control of a seizure disorder.
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- Active ethanol or drug abuse, excluding tobacco use.
- If female, are pregnant, planning on becoming pregnant in the next 6 months or breast-feeding.
- Patients with a known hypersensitivity to sevelamer or any constituents of either study drug.
- Patients who have participated in a study of an investigational drug/device during the 30 days preceding the start of the screening period.
- Patients who have any other condition, which in the opinion of the investigator will prohibit the patient's participation in the study.
- Patient is unable to comply with the requirements of the protocol.
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
United Kingdom7 sites
University Hospital ,Queen Elizabeth Hospital
Birmingham, B15 2TH
High Wycombe Hospital
Buckinghamshire, HP11 2TT
University of Wales College of Medicine
Cardiff, CF 14 4XN
Glasgow Western Infirmary
Glasgow, G11 6NT
Royal Hospital The Royal London
London, E1 1BB
Milton Keynes General Hospital
Milton Keynes, MK6 5LD
The Churchill Hospital, Oxford Radcliffe Hospitals NHS Trust
Oxford, OX3 7LJ
Denmark3 sites
Aarhus University Hospital
Århus N, DN-8200
Fredericia Sygehus
Fredericia, DN-7000
Copenhagen University Hospital
Herlev, DN-2730
Italy2 sites
Ospedale civico e benfratelli
Palermo, IT-90127
Ospedale San Bortolo
Vicenza, IT-36100
Spain2 sites
Fundacion Jimenez Diaz
Madrid, ES-28040
Hospital Universitario La Paz
Madrid, ES-28046
About this study
Official title: An Open Label, Randomized, Parallel Design Study to Investigate the Efficacy and Safety of Sevelamer Hydrochloride (Renagel®) Compared With Calcium Acetate in Peritoneal Dialysis Patients
The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal dialysis.
- Conditions
- Peritoneal Dialysis, Chronic Kidney Disease
- Being tested
- Sevelamer Hydrochloride (Renagel®), Calcium acetate (PhosLo® )
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevelamer Hydrochloride (Renagel®)Drug
Sevelamer hydrochloride three times per day with each meal
Calcium acetate (PhosLo® )Drug
Calcium acetate three times per day with each meal
| Study group | Role | What they receive |
|---|---|---|
| Sevelamer Hydrochloride (Renagel®) | Experimental | Not described Receives: Drug: Sevelamer Hydrochloride (Renagel®) |
| Calcium acetate (PhosLo® ) | Active comparator | Not described Receives: Drug: Calcium acetate (PhosLo® ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effects of sevelamer dosed three times per day (TID) and calcium acetate dosed TID on serum phosphorus.
Measured: 12 weeks
Secondary outcomes (3)
Serum calcium- phosphorus (CaxPO4) product
Measured: 12 weeks
Serum lipids - total and LDL cholesterol, non- HDL cholesterol, HDL, triglycerides
Measured: 12 weeks
Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionMar 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196755
- Sponsor's protocol ID
- REN00304
- Status last verified
- Mar 2015
- First submitted
- 15 Sep 2005
- Last updated
- 18 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Parallel Design Study to Investigate the Efficacy and Safety of Sevelamer Hydrochloride (Renagel®) Compared With Calcium Acetate in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT00196755
- Acronym / sponsor ID
- REN00304
- Conditions
- Peritoneal Dialysis, Chronic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevelamer Hydrochloride (Renagel®) | Experimental | Drug: Sevelamer Hydrochloride (Renagel®) |
| Calcium acetate (PhosLo® ) | Active comparator | Drug: Calcium acetate (PhosLo® ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willing and able to sign an informed consent form.
- Men or women aged 18 years of age or older.
- A diagnosis of Chronic Kidney Disease (CKD) and receiving peritoneal dialysis (Continuous cyclical peritoneal dialysis (CAPD), Automated peritoneal dialysis (APD) or Continuous cyclical peritoneal dialysis (CCPD) for 8 weeks or longer.
- In the opinion of the investigator, expected to receive peritoneal dialysis for the duration of the study.
- Will have a serum phosphorus level >1.76 mmol/L(5.50 mg/dL) after 2 weeks washout from their usual phosphate binder.
Key exclusion criteria (12 listed)
- Patients with a history of peritonitis in the last 30 days or > 2 episodes in the last 12 months
- Patient with active dysphagia, swallowing disorder, bowel obstruction, or severe gastrointestinal motility disorder.
- Patients who in the opinion of the investigator have poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, Human Immunodeficiency Virus (HIV) infection, or any clinically significant, unstable medical condition.
- Patients with any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not exclusion.
- Current use of an antiarrhythmic medication such as quinidine, procainamide, tocainide, or amiodarone for the control of arrhythmias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevelamer Hydrochloride (Renagel®)Sevelamer hydrochloride three times per day with each meal | Drug | Sevelamer Hydrochloride (Renagel®) |
| Calcium acetate (PhosLo® )Calcium acetate three times per day with each meal | Drug | Calcium acetate (PhosLo® ) |
Primary outcome
Compare the effects of sevelamer dosed three times per day (TID) and calcium acetate dosed TID on serum phosphorus.
Time frame: 12 weeks
3 secondary outcomes
Serum calcium- phosphorus (CaxPO4) product
Time frame: 12 weeks
Serum lipids - total and LDL cholesterol, non- HDL cholesterol, HDL, triglycerides
Time frame: 12 weeks
Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Genzyme, a Sanofi Company
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sevelamer Hydrochloride (Renagel®) and Calcium acetate (PhosLo® ) in people with Peritoneal Dialysis and Chronic Kidney Disease, run by Genzyme, a Sanofi Company at 17 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom, Denmark, Italy, Spain, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the effects of sevelamer dosed three times per day (TID) and calcium acetate dosed TID on serum phosphorus. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.