Trial Outcomes & Findings for The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan (NCT NCT01238588)

NCT ID: NCT01238588

Last Updated: 2017-07-31

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2017-07-31

Participant Flow

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).

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	12
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sevelamer Carbonate (Renvela) n=12 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

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

Outcome measures

Outcome measures
Measure	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.
Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score	0

PRIMARY outcome

Timeframe: Baseline and 6 months

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

Outcome measures

Outcome measures
Measure	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.
Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level	0

PRIMARY outcome

Timeframe: Baseline and 6 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	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.
Albumin Levels	0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	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.
Erythropoiesis Stimulating Agent (ESA) Dose Requirement	0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	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.
Hemoglobin Level	0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	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.
Rate of Cardiovascular Events	0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	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.
Hemodialysis Access Stenosis/Thrombosis	0

Adverse Events

Sevelamer Carbonate (Renvela)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sevelamer Carbonate (Renvela) n=12 participants at risk 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.
Gastrointestinal disorders Constipation	8.3% 1/12 • Number of events 1 • 6 months

Additional Information

Kambiz Zandi-Nejad

Brigham and Women's Hospital

Phone: 617-732-5500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place