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Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD

Primary Purpose

Chronic Kidney Disease

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Lanthanum carbonate

Placebo

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects meeting all of the criteria listed below may be included in the study:

≥18 years old.
Male, or non-pregnant, non-lactating females who agree to comply with any applicable contraceptive requirements of the protocol.
Been in the care of a physician for CKD for >2 months, and are not expected to begin dialysis for at least 6 months.
Screening serum c-terminal FGF23 > 50.0RU/mL.
Screening estimated glomerular filtration rate (eGFR) of 30-59mL/min/1.73m2 using the MDRD formula.
Normal serum phosphate (0.808-1.55mmol/L).
Endogenous 25-hydroxy Vitamin D levels >20ng/mL.
Adequate protein diet (includes 2-3 portions of protein-rich food per day).
An understanding, ability, and willingness to fully comply with study procedures and restrictions.
Ability to provide written, signed, and dated (personally) informed consent to participate in the study.

Exclusion Criteria

Vitamin D supplementation required.
Compounds containing calcium, phosphate, aluminium or magnesium required.
Acute renal failure.
Rapidly progressing glomerulonephritis.
Vegetarian diet.
Known allergy to iodine.
Clinically significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair subjects' ability to give informed consent or take part in or complete this clinical study.
Cirrhosis or other clinically significant liver disease (aspartate transaminase (AST) or alanine transaminase (ALT) >3 times the upper limit of normal or bilirubin >2 times the upper limit of normal).
Past (treated within the last 5 years) or present GI disorders including uncontrolled peptic ulcer, Crohn's disease (or other conditions where the integrity of the GI tract may be compromised), malignancy, or GI bleed within the last 6 months.
Life-threatening malignancy or current multiple myeloma.
Known to be Human Immunodeficiency Virus (HIV) positive.
History of poor compliance with diet or medication that in the Investigator's opinion may interfere with adherence to the protocol.
History of alcohol or other substance abuse within 6 months prior to screening.
Subjects must not have used another investigational medicinal product or taken part in a clinical trial within the last 30 days prior to enrolment.
Subjects who have previously been enrolled into this study and subsequently withdrawn.

Sites / Locations

Dr Pablo Urena Torres

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lanthanum carbonate

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)

FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels.

Secondary Outcome Measures

Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF)

Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF)

Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF)

Change From Baseline in Serum Phosphate Values at Week 12 (LOCF)

Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF)

Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF)

Full Information

NCT ID

NCT01128179

First Posted

May 20, 2010

Last Updated

May 24, 2021

Sponsor

Shire

1. Study Identification

Unique Protocol Identification Number

NCT01128179

Brief Title

Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD

Official Title

A Proof of Concept, Phase 2a, Double-blind, Parallel Group, Randomised, Placebo-controlled Study to Assess the Effect of Lanthanum Carbonate on Intact FGF23 in Normo-phosphataemic Subjects With Stage 3 Chronic Kidney Disease

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

December 6, 2010 (Actual)

Primary Completion Date

April 16, 2012 (Actual)

Study Completion Date

April 16, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shire

4. Oversight

5. Study Description

Brief Summary

To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lanthanum carbonate

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Lanthanum carbonate

Other Intervention Name(s)

Fosrenol/Foznol

Intervention Description

1000 mg in chewable tablets administered three times a day (for a total of 3000 mg/day) for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo chewable tablets administered 3 times a day for 12 weeks

Primary Outcome Measure Information:

Title

Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)

Description

Time Frame

12 Weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF)

Time Frame

12 Weeks

Title

Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF)

Time Frame

12 weeks

Title

Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF)

Time Frame

12 weeks

Title

Change From Baseline in Serum Phosphate Values at Week 12 (LOCF)

Time Frame

12 weeks

Title

Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF)

Time Frame

12 weeks

Title

Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF)

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects meeting all of the criteria listed below may be included in the study: ≥18 years old. Male, or non-pregnant, non-lactating females who agree to comply with any applicable contraceptive requirements of the protocol. Been in the care of a physician for CKD for >2 months, and are not expected to begin dialysis for at least 6 months. Screening serum c-terminal FGF23 > 50.0RU/mL. Screening estimated glomerular filtration rate (eGFR) of 30-59mL/min/1.73m2 using the MDRD formula. Normal serum phosphate (0.808-1.55mmol/L). Endogenous 25-hydroxy Vitamin D levels >20ng/mL. Adequate protein diet (includes 2-3 portions of protein-rich food per day). An understanding, ability, and willingness to fully comply with study procedures and restrictions. Ability to provide written, signed, and dated (personally) informed consent to participate in the study. Exclusion Criteria Vitamin D supplementation required. Compounds containing calcium, phosphate, aluminium or magnesium required. Acute renal failure. Rapidly progressing glomerulonephritis. Vegetarian diet. Known allergy to iodine. Clinically significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair subjects' ability to give informed consent or take part in or complete this clinical study. Cirrhosis or other clinically significant liver disease (aspartate transaminase (AST) or alanine transaminase (ALT) >3 times the upper limit of normal or bilirubin >2 times the upper limit of normal). Past (treated within the last 5 years) or present GI disorders including uncontrolled peptic ulcer, Crohn's disease (or other conditions where the integrity of the GI tract may be compromised), malignancy, or GI bleed within the last 6 months. Life-threatening malignancy or current multiple myeloma. Known to be Human Immunodeficiency Virus (HIV) positive. History of poor compliance with diet or medication that in the Investigator's opinion may interfere with adherence to the protocol. History of alcohol or other substance abuse within 6 months prior to screening. Subjects must not have used another investigational medicinal product or taken part in a clinical trial within the last 30 days prior to enrolment. Subjects who have previously been enrolled into this study and subsequently withdrawn.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

Facility Name

Dr Pablo Urena Torres

City

Saint Ouen

State/Province

Paris

ZIP/Postal Code

93400

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

24885942

Citation

Urena-Torres P, Prie D, Keddad K, Preston P, Wilde P, Wan H, Copley JB. Changes in fibroblast growth factor 23 levels in normophosphatemic patients with chronic kidney disease stage 3 treated with lanthanum carbonate: results of the PREFECT study, a phase 2a, double blind, randomized, placebo-controlled trial. BMC Nephrol. 2014 May 5;15:71. doi: 10.1186/1471-2369-15-71.

Results Reference

result

Learn more about this trial

Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD

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