NCT00211978

Brief Summary

The purpose of this study is to determine if calcium acetate (PhosLo) can control serum phosphorus in pre-dialysis patients with moderate to severe impairment of kidney function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2005

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

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

January 8, 2008

Status Verified

December 1, 2007

Enrollment Period

1.1 years

First QC Date

September 13, 2005

Last Update Submit

December 26, 2007

Conditions

HyperphosphatemiaKidney Failure

Keywords

PhosLo (Calcium acetate)

Outcome Measures

Primary Outcomes (1)

  • serum phosphorus

    weeks 5-24

Secondary Outcomes (2)

  • calcium x phosphorus product

    weeks 5-24

  • intact parathyroid hormone

    weeks 5-24

Study Arms (2)

PhosLo

EXPERIMENTAL
Drug: calcium acetate

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

calcium acetateDRUG

667 mg gelcaps, 1-3 t.i.d. (titrated to serum phosphorus level)

Also known as: PhosLo
PhosLo
placeboDRUG

gelcap, 1-3 t.i.d. (titrated to serum phosphorus level)

placebo

Eligibility Criteria

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

You may qualify if:

  • Non-dialyzed male or female patients with CKD, with a GFR of less than 30mL/min/1.73m² who have elevated serum phosphorus or who develop elevated serum phosphorus following washout from phosphorus-binding therapy.
  • Patients must have written informed consent
  • Negative serum pregnancy test if appropriate
  • Expected to be able to comply with protocol procedures and schedule

You may not qualify if:

  • Unstable angina pectoris
  • Severe congestive heart failure
  • Severe liver dysfunction
  • Severe malnutrition
  • Severe hyperparathyroidism
  • AIDS (HIV positive subjects without AIDS are not excluded)
  • Active malignancy for which the subject is receiving chemotherapy or radiation
  • Subject unlikely to complete the study
  • History of obstructed bowels or hypersensitivity to any of the study medications or their components
  • History of swallowing disorders such as dysphagia (that would prevent the subject from taking the study drug) severe gastrointestinal motility disorders, or major GI tract surgery
  • Participation in an investigational drug or device trial within 30 days of randomization
  • Subjects on Vitamin D therapy
  • Subjects with acute symptoms, in the last month, or current radiographic evidence of kidney stones
  • Subjects who have undergone renal transplant or receiving dialysis
  • Or any condition with makes patient participation not in the patients best interest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Sciences Center

San Antonio, Texas, 78229-3900, United States

Location

Related Publications (2)

  • 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

  • Qunibi W, Winkelmayer WC, Solomon R, Moustafa M, Kessler P, Ho CH, Greenberg J, Diaz-Buxo JA. A randomized, double-blind, placebo-controlled trial of calcium acetate on serum phosphorus concentrations in patients with advanced non-dialysis-dependent chronic kidney disease. BMC Nephrol. 2011 Feb 16;12:9. doi: 10.1186/1471-2369-12-9.

    PMID: 21324193DERIVED

MeSH Terms

Conditions

HyperphosphatemiaRenal Insufficiency

Interventions

calcium acetate

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Wajeh Y Qunibi, M.D.

    University of Texas Health Science Center San Antonio

    STUDY CHAIR

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
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

May 1, 2005

Primary Completion

June 1, 2006

Study Completion

October 1, 2006

Last Updated

January 8, 2008

Record last verified: 2007-12

Locations

US(1)