Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01130831
First received: May 20, 2010
Last updated: July 9, 2013
Last verified: July 2013
  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 Intervention
End Stage Renal Disease
Drug: Lanthanum carbonate

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:

Primary Outcome Measures:
  • Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.

  • Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.


Secondary Outcome Measures:
  • Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.

  • Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.

  • Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.

  • Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.

  • Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.

  • Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.

  • Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.

  • Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    iPTH levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for iPTH of 150-300 pg/mL

  • Percent Change From Baseline in Phosphorous Levels at 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Calcium Levels at 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in iPTH Levels at 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL

  • Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL

  • Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Hypercalcemia is defined as total serum calcium level above 11.22 mg/dL.

  • Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Hypercalcemia defined as total serum calcium above 11.22 mg/dL

  • Change From Baseline in Vitamin D Dose at 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Number of Tablets Per Day [ Time Frame: 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)
Intervention Details:
    Drug: Lanthanum carbonate
    Other Name: Fosrenol
  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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Karlstraße
Düsseldorf, Germany, 40210
Dialysezentrum Süd
Düsseldorf, Germany, 40589
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
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01130831     History of Changes
Other Study ID Numbers: SPD405-702
Study First Received: May 20, 2010
Results First Received: April 19, 2013
Last Updated: July 9, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on November 27, 2014