NCT01191762

Brief Summary

The hypothesis underlying this study is that phosphate interferes with PTH-mediated calcium reabsorption in the distal nephron and thereby necessitates supranormal \[PTH\]to maintain normocalcemia in chronic kidney disease. This study will examine the hypothesis with measures of phosphate homeostasis and calcium reabsorption. A double-blind trial of the intestinal phosphate binder sevelamer carbonate will be employed to examine whether reductions in phosphate influx alter distal nephron phosphate concentration and the \[PTH\] required for calcium reabsorption in the expected manner.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 31, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 31, 2014

Completed
Last Updated

November 1, 2016

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

August 27, 2010

Results QC Date

November 13, 2013

Last Update Submit

September 26, 2016

Conditions

HyperparathyroidismChronic Kidney Disease

Keywords

secondary hyperparathyroidismphosphatecalciumchronic kidney disease

Outcome Measures

Primary Outcomes (1)

  • Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate

    This outcome measure documented the effect of intestinal phosphate-binding on \[PTH\]. Fractional change was calculated as (\[PTH\]post - \[PTH\]pre)/\[PTH\]pre, where 'pre' and 'post' referred respectively to baseline \[PTH\] (before treatment) and \[PTH\] after four weeks of treatment. Reductions were cited as negative numbers, and increments were cited as positive numbers.

    4 weeks

Study Arms (2)

sevelamer carbonate

ACTIVE COMPARATOR

2400 mg (3 pills) with each meal

Drug: sevelamer carbonate

placebo control

PLACEBO COMPARATOR

3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.

Drug: placebo

Interventions

sevelamer carbonateDRUG

2400 mg with each meal for 4 weeks

Also known as: Renvela (Genzyme)
sevelamer carbonate
placeboDRUG

3 tablets with each meal

placebo control

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • eGFR \< 60 ml/min
  • age at least 18 years

You may not qualify if:

  • any primary parathyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stratton Veterans Affairs Medical Center

Albany, New York, 12208, United States

Location

Related Publications (4)

  • Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

    PMID: 40576086DERIVED

  • Phelps KR, Mason DL. Parathyroid Hormone, Fibroblast Growth Factor 23, and Parameters of Phosphate Reabsorption. Am J Nephrol. 2018;47(5):343-351. doi: 10.1159/000489270. Epub 2018 May 18.

    PMID: 29779023DERIVED

  • Phelps KR, Mason DL, Stote KS. Phosphate homeostasis, parathyroid hormone, and fibroblast growth factor 23 in stages 3 and 4 chronic kidney disease. Clin Nephrol. 2016 May;85(5):251-61. doi: 10.5414/CN108686.

    PMID: 26951967DERIVED

  • Phelps KR, Mason DL. Parameters of phosphorus homeostasis at normal and reduced GFR: theoretical considerations. Clin Nephrol. 2015 Mar;83(3):167-76. doi: 10.5414/cn108367.

    PMID: 25685872DERIVED

MeSH Terms

Conditions

HyperparathyroidismRenal Insufficiency, ChronicHyperparathyroidism, Secondary

Interventions

Sevelamer

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic Chemicals

Limitations and Caveats

All intended measurements were made. The desired number of participants was recruited.

Results Point of Contact

Title
Kenneth R. Phelps, M.D.
Organization
Kenneth R. Phelps, M.D.
kenneth.phelps@va.gov
518-626-5641

Study Officials

  • Kenneth R. Phelps, M.D.

    Stratton VAMC, Albany, NY

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2010

First Posted

August 31, 2010

Study Start

April 1, 2010

Primary Completion

August 1, 2012

Study Completion

April 1, 2013

Last Updated

November 1, 2016

Results First Posted

July 31, 2014

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)