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

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01238588
• Collaborator: (none)
• Enrollment: 24
• Locations: 10
• Arm: 1
• Actual Duration (Months): 58
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0

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
Dialysis; Cardiovascular Disease; Atherosclerosis; Inflammation; Hyperphosphatemia	Drug: Sevelamer Carbonate (Renvela)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan
• Actual Study Start Date: Jun 10, 2011
• Actual Primary Completion Date: Apr 8, 2016
• Actual Study Completion Date: Apr 8, 2016

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: Sevelamer carbonate Renvela

Outcome Measures

Primary Outcome Measures

1. Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score [Baseline and 6 months]

2. Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level [Baseline and 6 months]

3. Changes in Interleukin-6 (IL-6) Level [Baseline and 6 months]

Secondary Outcome Measures

1. Albumin Levels [Baseline and 6 months]

2. Erythropoiesis Stimulating Agent (ESA) Dose Requirement [Baseline and 6 months]

3. Hemoglobin Level [Baseline and 6 months]

4. Rate of Cardiovascular Events [Baseline and 6 months]

5. Hemodialysis Access Stenosis/Thrombosis [Baseline and 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

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.

• Responsible Party: Kambiz Zandi-Nejad, MD, Instructor in Medicine, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT01238588
• Other Study ID Numbers: 2010P002213
• First Posted: Nov 10, 2010
• Last Update Posted: Jul 31, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Cardiovascular Diseases; Atherosclerosis; Hyperphosphatemia; Inflammation; Plaque, Atherosclerotic; Sevelamer

Study Results

Participant Flow

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

1. Primary Outcome

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

2. Primary Outcome

Title	Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level
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

3. Primary Outcome

Title	Changes in Interleukin-6 (IL-6) Level
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

4. Secondary Outcome

Title	Albumin Levels
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

5. Secondary Outcome

Title	Erythropoiesis Stimulating Agent (ESA) Dose Requirement
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

6. Secondary Outcome

Title	Hemoglobin Level
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

7. Secondary Outcome

Title	Rate of Cardiovascular Events
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

8. Secondary Outcome

Title	Hemodialysis Access Stenosis/Thrombosis
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
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

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.

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.