HyperphosphatemiaPhase 2NCT01574326
An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease
A Phase 2 study testing Sevelamer carbonate in people with Hyperphosphatemia and Chronic Kidney Disease, run by Genzyme, a Sanofi Company at 32 sites in 5 countries.
Trial summary
Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to Evaluate the safety and tolerability of sevelamer carbonate Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hyperphosphatemia, Chronic Kidney Disease
- What is being tested?
- Sevelamer carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 32 sitesin 5 countries
- Study dates
- May 2012to Jun 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The participant had CKD requiring dialysis or CKD not on dialysis with an estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m^2 based on central laboratory results.
- The participant had a serum phosphorus level greater than the age appropriate upper limit of normal based on central laboratory results.
Who cannot join
- The participant had active dysphagia, swallowing disorders or a predisposition to or current bowel obstruction, ileus or severe gastrointestinal motility disorder(s) including severe constipation, or major gastrointestinal tract surgery.
- The participant had a non-renal case of hyperphosphatemia.
Trial locations and contacts
32 sites in 5 countries.
32 sites in 5 countries
United States23 sites
Investigational Site Number 8007
Atlanta, Georgia, 30322
Investigational Site Number 8012
Baltimore, Maryland, 21287
Investigational Site Number 8003
Birmingham, Alabama, 35205
Investigational Site Number 8005
Birmingham, Alabama, 35205
Investigational Site Number 8008
Boston, Massachusetts, 02115
Investigational Site Number 8018
Buffalo, New York, 14222
Investigational Site Number 8002
Charlottesville, Virginia, 22908
Investigational Site Number 8026
Dallas, Texas, 75390
Investigational Site Number 8020
Detroit, Michigan, 48201
Investigational Site Number 8009
Greenville, North Carolina, 27834
Investigational Site Number 8016
Houston, Texas, 77030
Investigational Site Number 8019
Iowa City, Iowa
Investigational Site Number 8022
Kansas City, Missouri, 64108
Investigational Site Number 8017
Livingston, New Jersey, 07039
Investigational Site Number 8013
Los Angeles, California, 90024
Investigational Site Number 8025
Orlando, Florida, 32806
Investigational Site Number 8011
Philadelphia, Pennsylvania, 19104
Investigational Site Number 8010
Portland, Oregon, 97201-3098
Investigational Site Number 8027
Richmond, Virginia, 23298-0034
Investigational Site Number 8001
San Antonio, Texas, 78229
Investigational Site Number 8014
San Francisco, California, 94143
Investigational Site Number 8006
Seattle, Washington, 98105
Investigational Site Number 8023
St Louis, Missouri, 63110
France3 sites
Investigational Site Number 8101
Bordeaux, 33076
Investigational Site Number 8102
Bron, 69677
Investigational Site Number 8103
Paris, 75935
Germany2 sites
Investigational Site Number 8201
Berlin, 13353
Investigational Site Number 8202
Marburg, 35033
Lithuania2 sites
Investigational Site Number 8302
Kaunas, 50009
Investigational Site Number 8301
Vilnius, 08406
Poland2 sites
Investigational Site Number 8402
Gdansk
Investigational Site Number 8401
Krakow, 301-663
About this study
Official title: A 2-Week, Randomized, Placebo-Controlled, Fixed Dose Period Followed by a 6-Month, Single-Arm, Open-Label, Dose Titration Period Study to Investigate the Efficacy and Safety of Sevelamer Carbonate in Hyperphosphatemic Pediatric Patients With Chronic Kidney Disease
Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to
- Evaluate the safety and tolerability of sevelamer carbonate
- Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus
Read the detailed description
The study was divided into 3 periods: a phosphate binder washout Period; a randomized, double-blind, placebo-controlled, Fixed Dose Period; and an open-label, sevelamer carbonate Dose Titration Period.
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease
- Being tested
- Placebo, Sevelamer carbonate
- Keywords
- Chronic Kidney Disease, Pediatric, Sevelamer Carbonate, Hyperphosphatemia
- Medical subject headings
- Hyperphosphatemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets
Sevelamer carbonateDrug
Also called Renvela®
0.8 g sachets of powder for oral suspension or 800 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate | Placebo comparator | Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP). Receives: Drug: Placebo; Drug: Sevelamer carbonate |
| FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate | Experimental | Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP. Receives: Drug: Placebo; Drug: Sevelamer carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (Week 0) to Week 2 in Serum Phosphorus
Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.
Measured: Baseline, Week 2
Treatment - Emergent Adverse Events (AEs)
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.
Measured: Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)
Secondary outcomes (1)
Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus
Full analysis set for dose titration period (FAS-DTP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to Week 28/Early Termination was calculated.
Measured: Baseline, Week 28/Early Termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperphosphatemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574326
- Sponsor's protocol ID
- SVCARB07609
- Other IDs
- 2011-002329-23, DRI12793
- Status last verified
- Jun 2016
- First submitted
- 6 Apr 2012
- Last updated
- 25 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Week, Randomized, Placebo-Controlled, Fixed Dose Period Followed by a 6-Month, Single-Arm, Open-Label, Dose Titration Period Study to Investigate the Efficacy and Safety of Sevelamer Carbonate in Hyperphosphatemic Pediatric Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01574326
- Acronym / sponsor ID
- SVCARB07609
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Pediatric, Sevelamer Carbonate, Hyperphosphatemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Posted 25 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to
- Evaluate the safety and tolerability of sevelamer carbonate
- Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus
Detailed description
The study was divided into 3 periods: a phosphate binder washout Period; a randomized, double-blind, placebo-controlled, Fixed Dose Period; and an open-label, sevelamer carbonate Dose Titration Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate | Placebo comparator | Drug: Placebo, Drug: Sevelamer carbonateParticipants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP). |
| FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate | Experimental | Drug: Placebo, Drug: Sevelamer carbonateParticipants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- The participant had CKD requiring dialysis or CKD not on dialysis with an estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m^2 based on central laboratory results.
- The participant had a serum phosphorus level greater than the age appropriate upper limit of normal based on central laboratory results.
Key exclusion criteria (2 listed)
- The participant had active dysphagia, swallowing disorders or a predisposition to or current bowel obstruction, ileus or severe gastrointestinal motility disorder(s) including severe constipation, or major gastrointestinal tract surgery.
- The participant had a non-renal case of hyperphosphatemia.
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 |
|---|---|---|
| PlaceboPlacebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets | Drug | FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate, FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate |
| Sevelamer carbonateAlso: Renvela®0.8 g sachets of powder for oral suspension or 800 mg tablets | Drug | FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate, FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate |
Primary outcome
Change From Baseline (Week 0) to Week 2 in Serum Phosphorus
Time frame: Baseline, Week 2
Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.
Treatment - Emergent Adverse Events (AEs)
Time frame: Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.
1 secondary outcome
Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus
Time frame: Baseline, Week 28/Early Termination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
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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
32 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sevelamer carbonate in people with Hyperphosphatemia and Chronic Kidney Disease, run by Genzyme, a Sanofi Company at 32 sites in 5 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 2 inclusion and 2 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 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, France, Germany, Lithuania, Poland. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline (Week 0) to Week 2 in Serum Phosphorus (time frame: Baseline, Week 2). The study lists 2 primary outcomes in all. 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 25 Jul 2016.