The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan
Study Details
Study Description
Brief 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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Sevelamer Carbonate (Renvela) Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela. |
Drug: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score [Baseline and 6 months]
- Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level [Baseline and 6 months]
- Changes in Interleukin-6 (IL-6) Level [Baseline and 6 months]
Secondary Outcome Measures
- Albumin Levels [Baseline and 6 months]
- Erythropoiesis Stimulating Agent (ESA) Dose Requirement [Baseline and 6 months]
- Hemoglobin Level [Baseline and 6 months]
- Rate of Cardiovascular Events [Baseline and 6 months]
- Hemodialysis Access Stenosis/Thrombosis [Baseline and 6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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;
-
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
2 | Fresenius Boston-TKC | Boston | Massachusetts | United States | 02215 |
3 | BWH/FH/DCI Outpatient Dialysis Unit | Boston | Massachusetts | United States | |
4 | Fresenius Framingham (#1109) | Framingham | Massachusetts | United States | 01701 |
5 | Fresenius Marlborough (#3448) | Marlborough | Massachusetts | United States | 01752 |
6 | Fresenius Medford Dialysis (#1246) | Medford | Massachusetts | United States | 02155 |
7 | Fresenius Quincy (#1610) | Quincy | Massachusetts | United States | 02169 |
8 | Fresenius Roxbury (#1630) | Roxbury | Massachusetts | United States | 02119 |
9 | DCI Dialysis Unit-Somerville | Somerville | Massachusetts | United States | 02145 |
10 | Fresenius QCDC-Weymouth (#9144) | Weymouth | Massachusetts | United States | 02190 |
Sponsors and Collaborators
- Brigham and Women's Hospital
Investigators
- Principal Investigator: Kambiz Zandi-Nejad, MD, Brigham and Women's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2010P002213
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | 24 patients enrolled in the study by signing the consent form of which 12 started the study. The other 12 never started the study due to various reasons (eg voluntary withdrawal, termination due to infection, transplant). |
Arm/Group Title | Sevelamer Carbonate (Renvela) |
---|---|
Arm/Group Description | Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela. 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. |
Period Title: Overall Study | |
STARTED | 12 |
COMPLETED | 9 |
NOT COMPLETED | 3 |
Baseline Characteristics
Arm/Group Title | Sevelamer Carbonate (Renvela) |
---|---|
Arm/Group Description | Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela. 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. |
Overall Participants | 12 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
10
83.3%
|
>=65 years |
2
16.7%
|
Sex: Female, Male (Count of Participants) | |
Female |
4
33.3%
|
Male |
8
66.7%
|
Region of Enrollment (participants) [Number] | |
United States |
12
100%
|
Outcome Measures
Title | Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score |
---|---|
Description | |
Time Frame | Baseline and 6 months |
Outcome Measure Data
Analysis Population Description |
---|
Scans were done but not analyzed due to early study termination (per funding source). |
Arm/Group Title | Sevelamer Carbonate (Renvela) |
---|---|
Arm/Group Description | Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela. 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. |
Measure Participants | 0 |
0
|
Title | Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level |
---|---|
Description | |
Time Frame | Baseline and 6 months |
Outcome Measure Data
Analysis Population Description |
---|
Blood samples were collected but the measurements were not done due to early study termination (per funding source). |
Arm/Group Title | Sevelamer Carbonate (Renvela) |
---|---|
Arm/Group Description | Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela. 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. |
Measure Participants | 0 |
0
|
Title | Changes in Interleukin-6 (IL-6) Level |
---|---|
Description | |
Time Frame | Baseline and 6 months |
Outcome Measure Data
Analysis Population Description |
---|
Blood samples were collected but the measurements were not done due to early study termination (per funding source). |
Arm/Group Title | Sevelamer Carbonate (Renvela) |
---|---|
Arm/Group Description | Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela. 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. |
Measure Participants | 0 |
Title | Albumin Levels |
---|---|
Description | |
Time Frame | Baseline and 6 months |
Outcome Measure Data
Analysis Population Description |
---|
Clinical lab data for this outcome measure was not collected from the medical record (for research purpose) due to early termination of the study (per funding source) |
Arm/Group Title | Sevelamer Carbonate (Renvela) |
---|---|
Arm/Group Description | Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela. 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. |
Measure Participants | 0 |
0
|
Title | Erythropoiesis Stimulating Agent (ESA) Dose Requirement |
---|---|
Description | |
Time Frame | Baseline and 6 months |
Outcome Measure Data
Analysis Population Description |
---|
Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source). |
Arm/Group Title | Sevelamer Carbonate (Renvela) |
---|---|
Arm/Group Description | Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela. 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. |
Measure Participants | 0 |
0
|
Title | Hemoglobin Level |
---|---|
Description | |
Time Frame | Baseline and 6 months |
Outcome Measure Data
Analysis Population Description |
---|
Clinical lab data for this outcome measure was not collected from the medical record (for research purpose) due to early termination of the study (per funding source) |
Arm/Group Title | Sevelamer Carbonate (Renvela) |
---|---|
Arm/Group Description | Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela. 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. |
Measure Participants | 0 |
0
|
Title | Rate of Cardiovascular Events |
---|---|
Description | |
Time Frame | Baseline and 6 months |
Outcome Measure Data
Analysis Population Description |
---|
Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source). |
Arm/Group Title | Sevelamer Carbonate (Renvela) |
---|---|
Arm/Group Description | Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela. 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. |
Measure Participants | 0 |
0
|
Title | Hemodialysis Access Stenosis/Thrombosis |
---|---|
Description | |
Time Frame | Baseline and 6 months |
Outcome Measure Data
Analysis Population Description |
---|
Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source). |
Arm/Group Title | Sevelamer Carbonate (Renvela) |
---|---|
Arm/Group Description | Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela. 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. |
Measure Participants | 0 |
0
|
Adverse Events
Time Frame | 6 months | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Sevelamer Carbonate (Renvela) | |
Arm/Group Description | Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela. 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. | |
All Cause Mortality |
||
Sevelamer Carbonate (Renvela) | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Sevelamer Carbonate (Renvela) | ||
Affected / at Risk (%) | # Events | |
Total | 0/12 (0%) | |
Other (Not Including Serious) Adverse Events |
||
Sevelamer Carbonate (Renvela) | ||
Affected / at Risk (%) | # Events | |
Total | 1/12 (8.3%) | |
Gastrointestinal disorders | ||
Constipation | 1/12 (8.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Kambiz Zandi-Nejad |
---|---|
Organization | Brigham and Women's Hospital |
Phone | 617-732-5500 ext 34769 |
kzandinejad@partners.org |
- 2010P002213