Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy
This study has been completed.
Sponsor:
Shire Development LLC
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT01130831
First received: May 20, 2010
Last updated: December 20, 2012
Last verified: December 2012
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Purpose
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.
| Condition |
|---|
|
End Stage Renal Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Shire Development LLC:
Primary Outcome Measures:
- Serum phosphorous [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Serum calcium [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: No ]
- serum calcium-phosphorous product [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: No ]
- Intact parathyroid hormone [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: No ]
- Any routine bone biochemical markers [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: No ]
- Use of concomitant vitamin D therapy [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: No ]
- Use of calcium supplements [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: No ]
- Daily dose of phosphate binder [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 66 |
| Study Start Date: | May 2010 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Haemodialysis patients with hyperphosphataemia
Criteria
Inclusion Criteria:
Patients meeting all of the criteria listed below may be included in the study:
- Patients aged over 18 years
- Patients with ESRD on haemodialysis who are willing and able to provide written informed consent.
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.
- 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:
- Known or suspected intolerance or hypersensitivity to lanthanum, or any of the stated ingredients
- Patients with known hypophosphatemia (phosphate level below lower level of normal)
- Patients with severe hepatic impairment
- Patients with requirement for calcium supplementation for reasons other than CKD
- Pregnant or lactating women and women planning to become pregnant over the next 12 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130831
Locations
| Germany | |
| Dialyse Alsfeld | |
| Alsfeld, Germany, 36304 | |
| Nephrologische Praxis Altötting-Burghausen | |
| Altötting, Germany, 84503 | |
| Dialyse am Treptower Park | |
| Berlin, Germany, 12435 | |
| Dialyse Berlin | |
| Berlin, Germany, 12627 | |
| Dialysezentrum Cochem | |
| Cochem, Germany, 56812 | |
| Dialysezentrum Coesfeld | |
| Coesfeld, Germany, 48653 | |
| MVZ Caspar-David-Friedrich-Str. | |
| Dresden, Germany, 01217 | |
| Dialysezentrum Süd | |
| Düsseldorf, Germany, 40589 | |
| Dialysezentrum Karlstraße | |
| Düsseldorf, Germany, 40210 | |
| KfH-Nierenzentrum Eberswalde | |
| Eberswalde, Germany, 16225 | |
| Arzt für Dialyse, Facharzt für Innere Medizin und Nephrologie | |
| Essen, Germany, 45127 | |
| Dialysezentrum Lauerwald | |
| Gera, Germany, 07548 | |
| Dialysezentrum Grevenbroich | |
| Grevenbroich, Germany, 41516 | |
| Dialyse im Heidering | |
| Hannover, Germany, 30625 | |
| Dialysepraxen Herne und Wanne-Eickel | |
| Herne, Germany, 44623 | |
| Dialyse Herzberg | |
| Herzberg, Germany, 04916 | |
| Patienten-Heimversorgung | |
| Hildesheim, Germany, 31134 | |
| Dialysezentrum Facharzt für Innere Medizin und Nephrologie | |
| Homberg (Efze), Germany, 34576 | |
| Universitätsklinik des Saarlandes | |
| Homburg / Saar, Germany, 66421 | |
| Nierenzentrum Mannheim | |
| Mannheim, Germany, 68309 | |
| Dialysepraxis | |
| Meiningen, Germany, 98617 | |
| Dialyse Mettmann | |
| Mettmann, Germany, 40822 | |
| Nierenzentrum Bogenhausen | |
| München, Germany, 81925 | |
| Nephrologie Nettetal | |
| Nettetal, Germany, 41334 | |
| Dialysenzentrum Peine | |
| Peine, Germany, 31224 | |
| Facharzt für Innere Medizin und Nephrologie | |
| Potsdam, Germany, 14482 | |
| Facharzt für Innere Medizin und Nephrologie | |
| Quedlinburg, Germany, 6484 | |
| Nephrologische Praxis Schwetzingen | |
| Schwetzingen, Germany, 68723 | |
| PHV-Dialysezentrum Siegen | |
| Siegen, Germany, 57076 | |
| Nephrologisches Zentrum | |
| Villingen Schwenningen, Germany | |
| Dialysezentrum Worms | |
| Worms, Germany, 67547 | |
Sponsors and Collaborators
Shire Development LLC
More Information
No publications provided
| Responsible Party: | Shire Development LLC |
| ClinicalTrials.gov Identifier: | NCT01130831 History of Changes |
| Other Study ID Numbers: | SPD405-702 |
| Study First Received: | May 20, 2010 |
| Last Updated: | December 20, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |
ClinicalTrials.gov processed this record on May 19, 2013