Atherosclerosis, Cardiovascular Disease, Dialysis, Hyperphosphatemia, Inflammation
Conditions
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).
Interventions
DRUGSevelamer 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.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Cardiovascular Events | Baseline and 6 months |
| Albumin Levels | Baseline and 6 months |
| Hemodialysis Access Stenosis/Thrombosis | Baseline and 6 months |
| Erythropoiesis Stimulating Agent (ESA) Dose Requirement | Baseline and 6 months |
| Hemoglobin Level | Baseline and 6 months |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Sevelamer Carbonate (Renvela) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score
Time frame: Baseline and 6 months
Population: Scans were done but not analyzed due to early study termination (per funding source).
| Arm | Measure | Value |
|---|---|---|
| Sevelamer Carbonate (Renvela) | Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score | 0 |
Primary
Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level
Time frame: Baseline and 6 months
Population: Blood samples were collected but the measurements were not done due to early study termination (per funding source).
| Arm | Measure | Value |
|---|---|---|
| Sevelamer Carbonate (Renvela) | Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level | 0 |
Primary
Changes in Interleukin-6 (IL-6) Level
Time frame: Baseline and 6 months
Population: Blood samples were collected but the measurements were not done due to early study termination (per funding source).
Secondary
Albumin Levels
Time frame: Baseline and 6 months
Population: 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 | Measure | Value |
|---|---|---|
| Sevelamer Carbonate (Renvela) | Albumin Levels | 0 |
Secondary
Erythropoiesis Stimulating Agent (ESA) Dose Requirement
Time frame: Baseline and 6 months
Population: Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source).
| Arm | Measure | Value |
|---|---|---|
| Sevelamer Carbonate (Renvela) | Erythropoiesis Stimulating Agent (ESA) Dose Requirement | 0 |
Secondary
Hemodialysis Access Stenosis/Thrombosis
Time frame: Baseline and 6 months
Population: Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source).
| Arm | Measure | Value |
|---|---|---|
| Sevelamer Carbonate (Renvela) | Hemodialysis Access Stenosis/Thrombosis | 0 |
Secondary
Hemoglobin Level
Time frame: Baseline and 6 months
Population: 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 | Measure | Value |
|---|---|---|
| Sevelamer Carbonate (Renvela) | Hemoglobin Level | 0 |
Secondary
Rate of Cardiovascular Events
Time frame: Baseline and 6 months
Population: Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source).
| Arm | Measure | Value |
|---|---|---|
| Sevelamer Carbonate (Renvela) | Rate of Cardiovascular Events | 0 |