NCT01002872

Brief Summary

The aim of the study is to assess the effects of the drug lanthanum carbonate (a phosphorus binder drug) on c-terminal and on FGF23 levels in patients with Chronic Kidney Disease (CKD). Targeting FGF23 measurement in CKD patients may impact both the progression of kidney disease and patient mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

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

October 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
10.8 years until next milestone

Results Posted

Study results publicly available

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2.6 years

First QC Date

October 27, 2009

Results QC Date

March 1, 2021

Last Update Submit

September 19, 2023

Conditions

Metabolic Bone Disease

Keywords

FGF23CKDFosrenolHyperphosphatemia

Outcome Measures

Primary Outcomes (1)

  • Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline

    Mean change from baseline of FGF23 in subjects treated with Lanthanum Carbonate verse placebo at 60 days

    Baseline, 60 days

Secondary Outcomes (8)

  • Calcium Mean Change From Baseline

    Baseline, 60 days

  • Serum Phosphate Mean Change From Baseline

    Baseline, 60 days

  • Change From Baseline Serum Parathyroid Hormone

    Baseline, 60 days

  • 1,25 Dihydroxyvitamin D 3 Mean Change From Baseline

    Baseline, 60 days

  • 25 Hydroxyvitamin D Mean Change From Baseline

    Baseline, 60 days

  • +3 more secondary outcomes

Study Arms (2)

Lanthanum Carbonate (Fosrenol)

ACTIVE COMPARATOR

Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol)

Drug: Lanthanum Carbonate (Fosrenol)

Placebo

PLACEBO COMPARATOR

Subject will receive placebo

Drug: placebo

Interventions

Lanthanum Carbonate (Fosrenol)DRUG

Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill three times a day (TID) Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus \<3.5mg/dL Reduce to 1 pill twice a day (BID). If Phosphorus \>5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is \<3.5mg/dL Reduce to 1 pill daily. If phosphorus \>5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus \<3.5mg/dL stop the drug If phosphorus is \>5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner

Also known as: Fosrenol
Lanthanum Carbonate (Fosrenol)
placeboDRUG

Initial dose of placebo will be 1 pill three times a day

Also known as: sugar pill
Placebo

Eligibility Criteria

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

You may qualify if:

  • Males and non-pregnant females ages 18 years of age or older
  • Estimated glomerular filtration rate (GFR) between 15-60 ml/min/1.73m
  • Serum phosphate \> 3.5 mg/dL
  • Fibroblast growth factor 2 (FGF2) \> 100 relative units per milliliter (RU/mL)
  • Corrected serum calcium \>8.0mg/dL

You may not qualify if:

  • Current use of a phosphate binder
  • Corrected serum calcium \<8.0mg/dL
  • Current use of prescription-based vitamin D therapy
  • Acute kidney injury in last 3 months
  • Significant GI disorder
  • History of allergic reaction or sensitivity to lanthanum carbonate
  • History of non compliance with visits or medications that preclude study compliance in the opinion of the investigator
  • Pregnant or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Related Publications (6)

  • Stubbs JR, Quarles LD. Fibroblast growth factor 23: uremic toxin or innocent bystander in chronic kidney disease? Nephrol News Issues. 2009 May;23(6):33-4, 36-7.

    PMID: 19534362BACKGROUND

  • Saji F, Shiizaki K, Shimada S, Okada T, Kunimoto K, Sakaguchi T, Hatamura I, Shigematsu T. Regulation of fibroblast growth factor 23 production in bone in uremic rats. Nephron Physiol. 2009;111(4):p59-66. doi: 10.1159/000210389. Epub 2009 Apr 1.

    PMID: 19339809BACKGROUND

  • Ibrahim S, Rashed L. Serum fibroblast growth factor-23 levels in chronic haemodialysis patients. Int Urol Nephrol. 2009;41(1):163-9. doi: 10.1007/s11255-008-9466-0. Epub 2008 Oct 7.

    PMID: 18839328BACKGROUND

  • Moe SM, Chen NX, Seifert MF, Sinders RM, Duan D, Chen X, Liang Y, Radcliff JS, White KE, Gattone VH 2nd. A rat model of chronic kidney disease-mineral bone disorder. Kidney Int. 2009 Jan;75(2):176-84. doi: 10.1038/ki.2008.456. Epub 2008 Sep 17.

    PMID: 18800026BACKGROUND

  • Fliser D, Kollerits B, Neyer U, Ankerst DP, Lhotta K, Lingenhel A, Ritz E, Kronenberg F; MMKD Study Group; Kuen E, Konig P, Kraatz G, Mann JF, Muller GA, Kohler H, Riegler P. Fibroblast growth factor 23 (FGF23) predicts progression of chronic kidney disease: the Mild to Moderate Kidney Disease (MMKD) Study. J Am Soc Nephrol. 2007 Sep;18(9):2600-8. doi: 10.1681/ASN.2006080936. Epub 2007 Jul 26.

    PMID: 17656479BACKGROUND

  • Fukagawa M, Kazama JJ. FGF23: its role in renal bone disease. Pediatr Nephrol. 2006 Dec;21(12):1802-6. doi: 10.1007/s00467-006-0230-3. Epub 2006 Aug 24.

    PMID: 16932898BACKGROUND

MeSH Terms

Conditions

Bone Diseases, MetabolicHyperphosphatemia

Interventions

lanthanum carbonateSugars

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPhosphorus Metabolism Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

Title
Dr Stuart Sprague
Organization
Northshore University Healthsystem
ssprague@northshore.org
847-570-1761

Study Officials

  • Stuart M Sprague, DO

    Endeavor Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Nephrology and Hypertension Professor of Medicine University of Chicago Medical School

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 28, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2012

Study Completion

December 1, 2012

Last Updated

September 21, 2023

Results First Posted

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

Data will be compiled into a manuscript

Locations

US(1)