Not provided
Not provided
Not provided
Not provided
Not provided
The study stopped due to lack of funding.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevelamer Carbonate (Renvela) | Drug | 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 | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Albumin Levels | Baseline and 6 months | |
| Erythropoiesis Stimulating Agent (ESA) Dose Requirement | Baseline and 6 months | |
| Hemoglobin Level |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kambiz Zandi-Nejad, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Fresenius Boston-TKC |
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).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sevelamer Carbonate (Renvela) | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline and 6 months |
| Rate of Cardiovascular Events | Baseline and 6 months |
| Hemodialysis Access Stenosis/Thrombosis | Baseline and 6 months |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| BWH/FH/DCI Outpatient Dialysis Unit | Boston | Massachusetts | United States |
| Fresenius Framingham (#1109) | Framingham | Massachusetts | 01701 | United States |
| Fresenius Marlborough (#3448) | Marlborough | Massachusetts | 01752 | United States |
| Fresenius Medford Dialysis (#1246) | Medford | Massachusetts | 02155 | United States |
| Fresenius Quincy (#1610) | Quincy | Massachusetts | 02169 | United States |
| Fresenius Roxbury (#1630) | Roxbury | Massachusetts | 02119 | United States |
| DCI Dialysis Unit-Somerville | Somerville | Massachusetts | 02145 | United States |
| Fresenius QCDC-Weymouth (#9144) | Weymouth | Massachusetts | 02190 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sevelamer Carbonate (Renvela) | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score | Scans were done but not analyzed due to early study termination (per funding source). | Posted | Baseline and 6 months |
|
|
| |||||||||||||||||||||||||||||
| Primary | Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level | Blood samples were collected but the measurements were not done due to early study termination (per funding source). | Posted | Baseline and 6 months |
|
| ||||||||||||||||||||||||||||||
| Primary | Changes in Interleukin-6 (IL-6) Level | Blood samples were collected but the measurements were not done due to early study termination (per funding source). | Posted | Baseline and 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Albumin Levels | 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) | Posted | Baseline and 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Erythropoiesis Stimulating Agent (ESA) Dose Requirement | Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source). | Posted | Baseline and 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Hemoglobin Level | 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) | Posted | Baseline and 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Rate of Cardiovascular Events | Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source). | Posted | Baseline and 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Hemodialysis Access Stenosis/Thrombosis | Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source). | Posted | Baseline and 6 months |
|
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sevelamer Carbonate (Renvela) | 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. | 0 | 12 | 1 | 12 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
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.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kambiz Zandi-Nejad | Brigham and Women's Hospital | 617-732-5500 | 34769 | kzandinejad@partners.org |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D007249 | Inflammation |
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
|
|
|
|
|
|