NCT00557323 is a clinical trial of Lanthanum carbonate in Hyperphosphatemia, sponsored by Shire.

Who is sponsoring NCT00557323?

NCT00557323 is sponsored by Shire.

What drugs are being tested in NCT00557323?

Interventions in NCT00557323: Lanthanum carbonate.

What condition does NCT00557323 study?

NCT00557323 studies Hyperphosphatemia.

Is NCT00557323 still recruiting?

NCT00557323 is currently completed. Last updated 13 July 2021.

Are results published for NCT00557323?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-07-13 · How we verify

NCT00557323

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Long-term Effect of Lanthanum Carbonate on Bone

Completed Results posted Last updated 13 July 2021

What this trial tests

trial testing Lanthanum carbonate in Hyperphosphatemia in 34 participants. Completed in 31 August 2010.

Timeline

15 March 2007

Primary endpoint
31 August 2010

31 August 2010

Quick facts

Lead sponsor	Shire
Status	Completed
Study type	OBSERVATIONAL
Enrollment	34
Start date	15 March 2007
Primary completion	31 August 2010
Estimated completion	31 August 2010
Sites	19 locations across United Kingdom, United States, Germany

Drugs / interventions tested

Lanthanum carbonate — full drug profile →

Conditions studied

Hyperphosphatemia — all drugs for Hyperphosphatemia →

Sponsor

Shire — full company profile →

Who can join

Eligibility, any sex, with Hyperphosphatemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Study-emergent Bone-related Adverse Events (AEs) Primary · 5 years

Fracture (8 subjects)

Group	Value	95% CI
5-Year Observational Period	9

Arthralgia (1 subject)

Group	Value	95% CI
5-Year Observational Period	2

Hyperparathyroidism tertiary

Group	Value	95% CI
5-Year Observational Period	1

Flat feet

Group	Value	95% CI
5-Year Observational Period	1

Fracture nonunion

Group	Value	95% CI
5-Year Observational Period	1

Intervertebral disc protrusion

Group	Value	95% CI
5-Year Observational Period	1

Osteoarthritis

Group	Value	95% CI
5-Year Observational Period	1

Osteonecrosis

Group	Value	95% CI
5-Year Observational Period	1

Number of Study-emergent Deaths Secondary · 5 years

Group	Value	95% CI
5-Year Observational Period	3

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

5-Year Observational Period

Serious: 18/34 (53%)

Deaths: —

Serious adverse events (44 terms)

Reaction	System	5-Year Observational Period
Fracture	Musculoskeletal and connective tissue disorders	—
Angina pectoris	Cardiac disorders	—
Sepsis	Infections and infestations	—
Urosepsis	Infections and infestations	—
Ureteric stenosis	Renal and urinary disorders	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—
Fracture nonunion	Musculoskeletal and connective tissue disorders	—
Pancytopenia	Blood and lymphatic system disorders	—
Aortic valve stenosis	Cardiac disorders	—
Atrial fibrillation	Cardiac disorders	—
Cardiac arrest	Cardiac disorders	—
Cardiac failure	Cardiac disorders	—
Coronary artery disease	Cardiac disorders	—
Ventricular fibrillation	Cardiac disorders	—
Hyperparathyroidism tertiary	Endocrine disorders	—
Diarrhea	Gastrointestinal disorders	—
Asthenia	General disorders	—
General physical health deterioration	General disorders	—
Malaise	General disorders	—
Multi-organ failure	General disorders	—
Pyrexia	General disorders	—
Bronchitis acute	Infections and infestations	—
Diverticulitis	Infections and infestations	—
Endocarditis	Infections and infestations	—
Gangrene	Infections and infestations	—

Other adverse events (1 terms — click to expand)

Reaction	System	5-Year Observational Period
Fracture	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Fracture, Angina pectoris, Sepsis, Urosepsis, Ureteric stenosis, Osteoarthritis, Fracture nonunion, Pancytopenia.

Data from ClinicalTrials.gov NCT00557323 adverse events section.

Sponsor's own description

Patients enrolled in a previous study (SPD405-309), who were exposed to lanthanum carbonate (Fosrenol), were eligible to continue on any prescribed treatment for hyperphosphatemia, including lanthanum carbonate (Fosrenol), for an additional 5 years. Patients were being observed for any bone adverse events or other serious adverse events, as well as the collection of mortality data.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Lanthanum carbonate

Trials testing the same drug.

NCT02209636 — Phosphate Lowering in CKD Trial · Phase 4 · completed
NCT01128179 — Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD · Phase 2 · completed
NCT01130831 — Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy · completed
NCT00452478 — Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5 · Phase 4 · terminated
NCT00234702 — Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Ki · Phase 2 · completed

Other recruiting trials for Hyperphosphatemia

Currently open trials in the same condition.

NCT06933472 — A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China · Phase 3 · recruiting
NCT06664125 — Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemi · Phase 2 · recruiting
NCT06206135 — Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule · recruiting
NCT06186934 — Post Marketing Surveillance Study to Observe Safety and Effectiveness of NEPHOXIL ® in S. Korea Patients · recruiting
NCT03573089 — Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE) · NA · recruiting

Other Shire trials

Trials by the same sponsor.

NCT05067868 — A Study of Replagal in Children and Adults With Fabry Disease in India · Phase 4 · recruiting
NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism · Phase 3 · withdrawn
NCT04840667 — A Study of Replagal in Treatment-naïve Adults With Fabry Disease · Phase 3 · terminated
NCT04429984 — Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India · completed
NCT04440488 — ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study · Phase 4 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00557323 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shire
Last refreshed: 13 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00557323.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing