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NCT00767637 Clinical Trial

Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone

Hyperphosphatemia Clinical Trial

Official title:
Open Label, Non-controlled Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone in Patients With Hyperphosphatemia Receiving Dialysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00767637
Other study ID # 11810
Secondary ID Fosrenol
Status Completed
Phase Phase 2
First received October 6, 2008
Last updated June 19, 2014
Start date June 2005
Est. completion date October 2008

Study information
Verified date June 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing dialysis or plan to start dialysis before the initial administration of the study medication

Exclusion Criteria:

- Patients with severe hypocalcemia (adjusted serum calcium level of <7.5 mg/dL)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lanthanum Carbonate (BAY77-1931)
BAY77-1931 750mg, in the morning, day and evening

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in pre-dialysis serum phosphate levels Every 2 weeks Yes
Secondary Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL) Every 2 weeks Yes
Secondary Changes in corrected serum calcium level Every 2 weeks Yes
Secondary Changes in the product of serum calcium and phosphate Every 2 weeks Yes
Secondary Changes in serum intact-PHT levels Every 2 weeks Yes
Secondary Changes in bone metabolism markers Every 2 weeks Yes
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT02237534 - Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia Phase 4
Completed NCT01252771 - Phosphate Kinetic Modeling 2 Phase 4
Unknown status NCT01245517 - The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient N/A
Completed NCT01187628 - Long-term Study in Chronic Kidney Disease (Extension From Study 14817) Phase 3
Completed NCT00506441 - A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia Phase 3
Recruiting NCT04440696 - To Evaluate the Patient Tolerance, Pharmacodynamics and Pharmacokinetics of Lanthanum Polystyrene Sulfonate Powder Phase 1/Phase 2
Completed NCT01976572 - Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects Phase 1
Completed NCT01742585 - A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis Phase 3
Completed NCT01191255 - A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis Phase 3
Completed NCT01003223 - Phosphate Kinetic Modeling N/A
Completed NCT00505037 - A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis Phase 2
Completed NCT00508885 - The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients Phase 1/Phase 2
Completed NCT04551300 - A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients Phase 2
Completed NCT01955876 - Fosrenol Post-marketing Surveillance in Japan N/A
Completed NCT04579315 - Long-term Effects of the New Nordic Renal Diet in Patients With Moderate Chronic Kidney Disease N/A
Completed NCT03861247 - Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients Phase 3
Terminated NCT01725113 - Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol Phase 4
Recruiting NCT01238588 - The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan N/A
Completed NCT00542815 - A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia Phase 3
Completed NCT04549597 - Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia Phase 4

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