Clinical trial NCT01130831: Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy
Official title: A Phase IV, Multi-Centre, Non-interventional Study Evaluating the Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium Based Phosphate Binder Therapy on Serum Phosphorous Control, Concomitant Vitamin D Therapy and Bone Related Biochemical Parameters in End Stage Renal Disease Patients on Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Haemodialysis patients with hyperphosphataemia

Brief summary: To assess the percentage of patients on lanthanum carbonate, that achieve Kidney Disease Outcome Quality Initiative (KDOQI) guideline suggested values for serum phosphorous in patients previously treated with calcium-based phosphate binder therapy.


Eligibility criteria: Inclusion Criteria:

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

1. Patients aged over 18 years
2. Patients with ESRD on haemodialysis who are willing and able to provide written informed consent.
3. Patients on:

   * Lanthanum carbonate monotherapy for ≥1 month
   * Lanthanum carbonate monotherapy for ≤3 months
   * Calcium-based monotherapy for ≥3 months immediately prior to lanthanum carbonate therapy.
4. Values recorded in medical records detailing serum phosphorous, serum calcium-phosphorus product, iPTH, and medication ≤6 months prior to commencing lanthanum carbonate therapy and whilst on a calcium-based monotherapy.

Exclusion Criteria:

Patients are excluded from the study if any of the following criteria are met at screening:

1. Known or suspected intolerance or hypersensitivity to lanthanum, or any of the stated ingredients
2. Patients with known hypophosphatemia (phosphate level below lower level of normal)
3. Patients with severe hepatic impairment
4. Patients with requirement for calcium supplementation for reasons other than CKD
5. Pregnant or lactating women and women planning to become pregnant over the next 12 months

Primary outcomes:
measure: Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy
timeFrame: Baseline
measure: Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate
timeFrame: 12 months
Secondary outcomes:
measure: Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy
timeFrame: Baseline
measure: Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy
timeFrame: 12 months
measure: Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy
timeFrame: Baseline
measure: Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy
timeFrame: 12 months
measure: Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate
timeFrame: 12 months
measure: Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate
timeFrame: 12 months
measure: Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy
timeFrame: 12 months
measure: Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy
timeFrame: 12 months
measure: Percent Change From Baseline in Phosphorous Levels at 12 Months
timeFrame: Baseline and 12 months
measure: Percent Change From Baseline in Calcium Levels at 12 Months
timeFrame: Baseline and 12 months
measure: Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months
timeFrame: Baseline and 12 months
measure: Percent Change From Baseline in iPTH Levels at 12 Months
timeFrame: Baseline and 12 months
measure: Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months
timeFrame: Baseline and 12 months
measure: Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months
timeFrame: Baseline and 12 months
measure: Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy
timeFrame: Baseline
measure: Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate
timeFrame: 12 months
measure: Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy
timeFrame: Baseline
measure: Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate
timeFrame: 12 months
measure: Change From Baseline in Vitamin D Dose at 12 Months
timeFrame: Baseline and 12 months
measure: Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months
timeFrame: Baseline and 12 months
measure: Number of Tablets Per Day
timeFrame: 12 months
Other outcomes:
Locations:
city: Homberg
country: Germany
facility: Dialysezentrum Facharzt für Innere Medizin und Nephrologie
state: Hesse
city: Alsfeld
country: Germany
facility: Dialyse Alsfeld
city: Altötting
country: Germany
facility: Nephrologische Praxis Altötting-Burghausen
city: Berlin
country: Germany
facility: Dialyse am Treptower Park
city: Berlin
country: Germany
facility: Dialyse Berlin
city: Cochem
country: Germany
facility: Dialysezentrum Cochem
city: Coesfeld
country: Germany
facility: Dialysezentrum Coesfeld
city: Dresden
country: Germany
facility: MVZ Caspar-David-Friedrich-Str.
city: Düsseldorf
country: Germany
facility: Dialysezentrum Karlstraße
city: Düsseldorf
country: Germany
facility: Dialysezentrum Süd
city: Eberswalde
country: Germany
facility: KfH-Nierenzentrum Eberswalde
city: Essen
country: Germany
facility: Arzt für Dialyse, Facharzt für Innere Medizin und Nephrologie
city: Gera
country: Germany
facility: Dialysezentrum Lauerwald
city: Grevenbroich
country: Germany
facility: Dialysezentrum Grevenbroich
city: Hannover
country: Germany
facility: Dialyse im Heidering
city: Herne
country: Germany
facility: Dialysepraxen Herne und Wanne-Eickel
city: Herzberg
country: Germany
facility: Dialyse Herzberg
city: Hildesheim
country: Germany
facility: Patienten-Heimversorgung
city: Homburg / Saar
country: Germany
facility: Universitätsklinik des Saarlandes
city: Mannheim
country: Germany
facility: Nierenzentrum Mannheim
city: Meiningen
country: Germany
facility: Dialysepraxis
city: Mettmann
country: Germany
facility: Dialyse Mettmann
city: München
country: Germany
facility: Nierenzentrum Bogenhausen
city: Nettetal
country: Germany
facility: Nephrologie Nettetal
city: Peine
country: Germany
facility: Dialysenzentrum Peine
city: Potsdam
country: Germany
facility: Facharzt für Innere Medizin und Nephrologie
city: Quedlinburg
country: Germany
facility: Facharzt für Innere Medizin und Nephrologie
city: Schwetzingen
country: Germany
facility: Nephrologische Praxis Schwetzingen
city: Siegen
country: Germany
facility: PHV-Dialysezentrum Siegen
city: Villingen Schwenningen
country: Germany
facility: Nephrologisches Zentrum
city: Worms
country: Germany
facility: Dialysezentrum Worms
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: