DialysisNCT01238588

The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan

A study testing Sevelamer Carbonate (Renvela) in people with Dialysis and Cardiovascular Disease, run by Brigham and Women's Hospital at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The hypothesis is that switching calcium based phosphate binders to sevelamer carbonate will be associated with less inflammation including less atherosclerotic plaque inflammation (inflammation of the vessel walls). Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Dialysis, Cardiovascular Disease, Atherosclerosis
What is being tested?: Sevelamer Carbonate (Renvela)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 10 sitesUnited States
Study dates: 10 Jun 2011to 8 Apr 2016
Phase: Interventional
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A signed consent form;
Male or Female, 50 years or older;
Diagnosed with end stage renal disease (ESRD), on maintenance hemodialysis for at least three (3) months;
On calcium-based phosphate binders;
Subject must be able to understand and provide informed consent;
No known contraindications to therapy with sevelamer carbonate.

Who cannot join

Any patient with a medical condition or taking any medications that would be contraindicated with the use of sevelamer carbonate, such as history of bowel obstruction;
History of severe allergic reactions to the study medication;
History of active infection (other than a simple respiratory tract infection) or acute gouty attack within 2 weeks prior to enrollment;
Known serological positivity for Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus Antibody (HCV Ab) except dose with normal liver function tests (AST, ALT, Bilirubin, and Alkaline Phophatase) and no history of cirrhosis;
Elevation of liver function tests at time of entry (Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) > 2 times the upper limit of normal);
History of drug, alcohol, or chemical abuse within 6 months prior to enrollment;

Show all 11Show fewer

History of malignancy except those adequately treated, has completed treatment and clinically in remission for more than 6 month; adequately treated in-situ cervical carcinoma, or adequately treated basal or squamous cell carcinoma of the skin;
History of an inflammatory disease such as systemic lupus erythematosus (SLE), rheumatoid arthritis or ulcerative colitis except those in remission for more than 6 months;
Patients currently on sevelamer carbonate or sevelamer chloride or history of taking them for more than a week in the past three months;
Patients receiving chronic anti-inflammatory therapy;
Patients in whom FDG-PET/CT dual scans are contraindicated.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Brigham and Women's Hospital
Boston, Massachusetts, 02115
Fresenius Boston-TKC
Boston, Massachusetts, 02215
BWH/FH/DCI Outpatient Dialysis Unit
Boston, Massachusetts
Fresenius Framingham (#1109)
Framingham, Massachusetts, 01701
Fresenius Marlborough (#3448)
Marlborough, Massachusetts, 01752
Fresenius Medford Dialysis (#1246)
Medford, Massachusetts, 02155
Fresenius Quincy (#1610)
Quincy, Massachusetts, 02169
Fresenius Roxbury (#1630)
Roxbury, Massachusetts, 02119
DCI Dialysis Unit-Somerville
Somerville, Massachusetts, 02145
Fresenius QCDC-Weymouth (#9144)
Weymouth, Massachusetts, 02190

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About this study

Conditions: Dialysis, Cardiovascular Disease, Atherosclerosis, Inflammation, Hyperphosphatemia
Being tested: Sevelamer Carbonate (Renvela)
Medical subject headings: Cardiovascular Diseases, Atherosclerosis, Inflammation, Hyperphosphatemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sevelamer Carbonate (Renvela)Drug
Also called Sevelamer carbonate, Renvela
Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines.

Study groups in NCT01238588
Study group	Role	What they receive
Sevelamer Carbonate (Renvela)	Other	Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela. Receives: Drug: Sevelamer Carbonate (Renvela)

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score
Measured: Baseline and 6 months
Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level
Measured: Baseline and 6 months
Changes in Interleukin-6 (IL-6) Level
Measured: Baseline and 6 months

Secondary outcomes (5)

Albumin Levels
Measured: Baseline and 6 months
Erythropoiesis Stimulating Agent (ESA) Dose Requirement
Measured: Baseline and 6 months
Hemoglobin Level
Measured: Baseline and 6 months
Rate of Cardiovascular Events
Measured: Baseline and 6 months
Hemodialysis Access Stenosis/Thrombosis
Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 20118 Apr 2016

First posted10 Nov 2010 (estimated)
Study start10 Jun 2011
Primary completion8 Apr 2016
Study completion8 Apr 2016

Why it stopped: The study stopped due to lack of funding.

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 DialysisStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01238588
Sponsor's protocol ID: 2010P002213
Status last verified: Jul 2017
First submitted: 9 Nov 2010
Last updated: 31 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan
ClinicalTrials.gov ID: NCT01238588
Acronym / sponsor ID: 2010P002213
Conditions: Dialysis, Cardiovascular Disease, Atherosclerosis, Inflammation, Hyperphosphatemia
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study stopped due to lack of funding.
Enrolment: 24 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Study start: 10 Jun 2011 (actual)
Primary completion: 8 Apr 2016 (actual)
Study completion: 8 Apr 2016 (actual)
First posted: 10 Nov 2010 (estimated)
Results: Posted 21 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sevelamer Carbonate (Renvela)	Other	Drug: Sevelamer Carbonate (Renvela)Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

A signed consent form;
Male or Female, 50 years or older;
Diagnosed with end stage renal disease (ESRD), on maintenance hemodialysis for at least three (3) months;
On calcium-based phosphate binders;
Subject must be able to understand and provide informed consent;

Key exclusion criteria (11 listed)

Any patient with a medical condition or taking any medications that would be contraindicated with the use of sevelamer carbonate, such as history of bowel obstruction;
History of severe allergic reactions to the study medication;
History of active infection (other than a simple respiratory tract infection) or acute gouty attack within 2 weeks prior to enrollment;
Known serological positivity for Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus Antibody (HCV Ab) except dose with normal liver function tests (AST, ALT, Bilirubin, and Alkaline Phophatase) and no history of cirrhosis;
Elevation of liver function tests at time of entry (Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) > 2 times the upper limit of normal);

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 Carbonate (Renvela)Also: Sevelamer carbonate, RenvelaPatients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines.	Drug	Sevelamer Carbonate (Renvela)

Primary outcome

Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score
Time frame: Baseline and 6 months
Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level
Time frame: Baseline and 6 months
Changes in Interleukin-6 (IL-6) Level
Time frame: Baseline and 6 months

5 secondary outcomes

Albumin Levels
Time frame: Baseline and 6 months
Erythropoiesis Stimulating Agent (ESA) Dose Requirement
Time frame: Baseline and 6 months
Hemoglobin Level
Time frame: Baseline and 6 months
Rate of Cardiovascular Events
Time frame: Baseline and 6 months
Hemodialysis Access Stenosis/Thrombosis
Time frame: Baseline and 6 months

Results and safety

Results posted to the registry on 21 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sevelamer Carbonate (Renvela)	12	9

Primary outcome: Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score

Time frame: Baseline and 6 months

Measure	Sevelamer Carbonate (Renvela) n = 0
Value	0

Population analysed: Scans were done but not analyzed due to early study termination (per funding source).

Primary outcome: Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level

Time frame: Baseline and 6 months

Measure	Sevelamer Carbonate (Renvela) n = 0
Value	0

Population analysed: Blood samples were collected but the measurements were not done due to early study termination (per funding source).

Primary outcome: Changes in Interleukin-6 (IL-6) Level

Time frame: Baseline and 6 months

Population analysed: Blood samples were collected but the measurements were not done due to early study termination (per funding source).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sevelamer Carbonate (Renvela)	0 of 12 (0%)	1 of 12 (8.3%)	Not reported

Limitations and caveats (from the sponsor): Enrollment was much slower than anticipated due to logistical reasons, study at the direction of funding source terminated early and therefore none of the collected samples were analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruiting
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Kidney Failure
RecruitingObservational study
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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.

Kambiz Zandi-Nejad, MD principal investigator

Brigham and Women's Hospital

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sevelamer Carbonate (Renvela) in people with Dialysis and Cardiovascular Disease, run by Brigham and Women's Hospital at 10 sites in United States.

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 6 inclusion and 11 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 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jun 2017). 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?

Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score (time frame: Baseline and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01238588.

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 31 Jul 2017.