Effect of Phosphate Binders on Markers of Vascular Health... | NCT01277497

Studies
Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4

NCT01277497

Sponsor

Albany College of Pharmacy and Health Sciences

Status

Terminated

Last Update Posted

Jan 14, 2016Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

Chronic Kidney Disease

Interventions

Sevelamer carbonate
Calcium acetate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

low enrollment

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2016Actual

Completion Date

Mar 2016Estimated

First Submitted Date

Jan 6, 2011

First Submission Date that Met QC Criteria

Jan 13, 2011

First Posted Date

Jan 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2016

Last Update Posted Date

Jan 14, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Darius Mason, PI, Albany College of Pharmacy and Health SciencesPrincipal Investigator

Lead Sponsor

Albany College of Pharmacy and Health SciencesOTHER

Collaborators

Name	Class
Albany Medical College	OTHER
Genzyme, a Sanofi Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Chronic kidney disease (CKD) patients often have high levels of a substance called fibroblast growth factor-23 (FGF-23), a phosphorus excreting hormone, which has been related to heart disease. As kidney function declines, less phosphorus is removed by the kidneys and as a result phosphorus accumulates in the blood. In response to elevated phosphorus levels, more FGF-23 is released to help facilitate the excretion of extra phosphorus into the urine. In addition to effects on FGF-23, increased phosphorus levels can lead to calcification (hardening) of the blood vessels in the CKD population.

Phosphate binding medicines are used in CKD patients to lower the amount of phosphorus absorbed by the stomach and intestines after eating meals and snacks. In patients with CKD, studies have shown that phosphate binders can lower FGF-23 levels in the blood. Lowering FGF-23 levels in CKD patients may also lower substances in the blood that cause calcification of blood vessels in the CKD population.

This study is being done to determine if using phosphate binders, either sevelamer carbonate or calcium acetate, in the earlier stages kidney disease (before dialysis) can decrease FGF-23 and biomarkers (substances in the blood) associated with hardening of the blood vessels and heart disease.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sevelamer carbonate	Experimental	1,600 mg (2 x 800 mg) three times daily with meals for a total of 12 weeks	Drug: Sevelamer carbonate
Calcium acetate	Active Comparator	1,334 mg (2 x 667 mg) three times daily with meals for a total of 12 weeks	Drug: Calcium acetate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sevelamer carbonate	Drug	Sevelamer carbonate 1,600 mg three times daily with meals	Sevelamer carbonate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome measure will be the change in FGF-23 concentrations		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in vascular calcification biomarker levels		12 weeks
Change in endothelial dysfunction biomarker levels.		12 Weeks
Change in inflammatory biomarker levels

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females ≥ 18 years of age at start of screening
CKD stage 3 or 4 defined by an eGFR 15 - 60 mL/min/1.73m2
Not expected to start dialysis for 8 months
Serum intact PTH < 500 pg/mL during screening period
On a stable ACE inhibitor/ARB regimen for 30 days prior to screening

Exclusion Criteria:

History of any of the following diseases: congestive heart failure, MI within the last 6 months, cerebrovascular accident, significant valvular disease, malignancy
Currently receiving erythropoiesis stimulating agent or IV iron therapy
History of inflammatory/autoimmune disease
History of polycystic kidney disease
HIV positive or AIDS
Pregnant or breastfeeding
Receiving activated Vitamin D analogs, nutritional vitamin D agents > 2,000 IU/day, or calcimimetics with in the last 3 months
Significant GI disorder
Proteinuria >3.5 g/24 hours

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Darius L Mason, Pharm.D.	Albany College of Pharmacy and Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Albany Medical Center South Clinical Campus		Albany	New York	12208	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34599865	Derived	Mason DL, Godugu K, Nnani D, Mousa SA. Effects of sevelamer carbonate versus calcium acetate on vascular calcification, inflammation, and endothelial dysfunction in chronic kidney disease. Clin Transl Sci. 2022 Feb;15(2):353-360. doi: 10.1111/cts.13151. Epub 2021 Oct 2.

ID	Term
D051436	Renal Insufficiency, Chronic
D061205	Vascular Calcification

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D011073	Polyamines
D000588	Amines
D009930	Organic Chemicals