Chronic Kidney DiseasePhase 3ASPIRENCT00833768
A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis
A Phase 3 study testing Sevelamer carbonate in people with Chronic Kidney Disease and Hyperphosphatemia, run by Genzyme, a Sanofi Company at 36 sites in 9 countries.
Trial summary
Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a safe and effective treatment for the control… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Hyperphosphatemia
- 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
- 5 participants
- Where
- 36 sitesin 9 countries
- Study dates
- Jan 2009to Sep 2009
- 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
- Serum phosphorus measurement ≥4.6 mg/dL (≥1.49 mmol/L) and ≤5.5 mg/dL (≤1.76 mmol/L after discontinuation of current phosphate binder therapy if applicable.
Who cannot join
- Active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.
Trial locations and contacts
36 sites in 9 countries.
36 sites in 9 countries
France7 sites
CHU Amiens Sud Service de Néphrologie
Amiens
Hôpital Pellegrin Service de Néphrologie
Bordeaux
Hôpital Européen G. Pompidou Département de Physiologie - Explorations Fonctionnelles et Radio-Isotopes
Cedex
Service de Néphrologie Hémodialyse Clinique de l'Orangerie
Cedex
Hôpital La Peyronie Nephrologie
Montpellier
Hôpital Tenon Néphrologie Hémodialyse
Paris
CHU de Brabois, Service de Néphrologie
Vandœuvre-lès-Nancy
Spain5 sites
Servicio de nefrología Fundacion Puigvert
Barcelona
Servicio de nefrología H. Arquitecto Marcide
Ferrol
Servicio de nefrología Hospital de Galdakao
Galdakao
Servicio de nefrología Fundación Hospital Alcorcón
Madrid
Servicio de Nefrología, Hospital Universitario Dr Peset,
Valencia
Austria4 sites
Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie und Hämodialyse
Graz
Uniklinik für Innere Medizin IV, Nephrologie und Hypertensiologie, Zentrum für Innere Medizin, Medizinische Universität Innsbruck
Innsbruck
Krankenhaus der Elisabethinen Linz, 3. Abteilung Schwerpunkt Nephrologie
Linz
Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie und Dialyse
Vienna
Hungary4 sites
Petz Aladár County Teaching hospital, Department ofimmunonephrology and hypertension
Győr
Kaposi Mór County Hospital Department of Nephrology
Kaposvár
Szekszárd EuroCare Dialysis Centre Number 7
Szekszárd
Kórház u. 1
Veszprém
Portugal4 sites
Hospital Santa Cruz
Carnaxide
Centro Hospitalar de Coimbra - Serviço de Nefrologia
Coimbra
Hospital da Universidade de Coimbra - Serviço de Nefrologia, Av.
Coimbra
Hospital de São João EPE - Serviço de Nefrologia
Porto
Germany3 sites
Klinikum Darmstadt
Darmstadt
Medizinische Hochschule Hannover
Hanover
Klinikum rechts der Isar der TU München, Nephrologie
München
Greece3 sites
Ippokrateio Hospital of Athens
Athens
University Hospital of Ioannina
Ioannina
General Hospital of Nikaia
Nikaia Peiraias
Italy3 sites
Azienda Ospedaliera di Lecco
Lecco
Fondazione Salvatore Maugeri, Divisione Nefrologia ed Emodialisi
Pavia
Unita' Operativa Complessa Di Nefrologia e Dialisi San Camillo Forlanini
Roma
Sweden3 sites
Department of Nephrology Sahlgrenska University Hospital
Gothenburg
NjurmedicinKliniken Centralsjukhuset
Karlstad
Njurmedicinska Kliniken, Karolinska Universitetssjukhuset, Solna
Stockholm
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease (CKD) Patients Not on Dialysis
Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 24 weeks.
- Conditions
- Chronic Kidney Disease, Hyperphosphatemia
- Being tested
- Sevelamer carbonate, Placebo for sevelamer carbonate
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevelamer carbonateDrug
Also called Renvela(TM)
800mg tablets to be taken orally with meals three times per day
Placebo for sevelamer carbonateDrug
Placebo tablets to be taken orally with meals three times per day
| Study group | Role | What they receive |
|---|---|---|
| Sevelamer carbonate | Active comparator | Not described Receives: Drug: Sevelamer carbonate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo for sevelamer carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum phosphorus levels
Measured: 24 weeks
Secondary outcomes (2)
To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum total cholesterol and low density lipoprotein (LDL) cholesterol
Measured: 24 weeks
To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum corrected calcium-phosphorus product (CaxP)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: After an extensive review,the ASPIRE in CKD study was terminated because it was not possible to complete the study in an appropriate time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 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
- NCT00833768
- Sponsor's protocol ID
- SVCARB00606
- Other IDs
- Eudra CT: 2007-003885-16
- Acronym
- ASPIRE
- Status last verified
- Mar 2015
- First submitted
- 29 Jan 2009
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease (CKD) Patients Not on Dialysis
- ClinicalTrials.gov ID
- NCT00833768
- Acronym / sponsor ID
- ASPIRE / SVCARB00606
- Conditions
- Chronic Kidney Disease, Hyperphosphatemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After an extensive review,the ASPIRE in CKD study was terminated because it was not possible to complete the study in an appropriate time frame.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 2 Feb 2009 (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.
Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevelamer carbonate | Active comparator | Drug: Sevelamer carbonate |
| Placebo | Placebo comparator | Drug: Placebo for sevelamer carbonate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Serum phosphorus measurement ≥4.6 mg/dL (≥1.49 mmol/L) and ≤5.5 mg/dL (≤1.76 mmol/L after discontinuation of current phosphate binder therapy if applicable.
Key exclusion criteria (1 listed)
- Active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.
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 carbonateAlso: Renvela(TM)800mg tablets to be taken orally with meals three times per day | Drug | Sevelamer carbonate |
| Placebo for sevelamer carbonatePlacebo tablets to be taken orally with meals three times per day | Drug | Placebo |
Primary outcome
To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum phosphorus levels
Time frame: 24 weeks
2 secondary outcomes
To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum total cholesterol and low density lipoprotein (LDL) cholesterol
Time frame: 24 weeks
To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum corrected calcium-phosphorus product (CaxP)
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: After an extensive review,the ASPIRE in CKD study was terminated because it was not possible to complete the study in an appropriate time frame.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
Related trials for Chronic Kidney Disease
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Active, not recruitingPhase 4
A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
Chronic Kidney Disease
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
36 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sevelamer carbonate in people with Chronic Kidney Disease and Hyperphosphatemia, run by Genzyme, a Sanofi Company at 36 sites in 9 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 24 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 36 sites in France, Spain, Austria, Hungary, Portugal and 4 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. 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 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 was stopped early (reason given: After an extensive review,the ASPIRE in CKD study was terminated because it was not possible to complete the study in an appropriate time frame.). Results are not available in the source record.
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?
To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum phosphorus levels (time frame: 24 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 24 Mar 2015.