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NCT01419327 Clinical Trial

Fosrenol Post-marketing Surveillance for Hemodialysis in Japan

Hyperphosphatemia Clinical Trial

— FOSRENOL-HD  

Official title:
Special Drug Use Investigation of Fosrenol (Long-term Investigation for Patients With Hemodialysis)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01419327
Other study ID # 15077
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 23, 2009
Est. completion date May 28, 2019

Study information
Verified date May 2020
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in hemodialysis who received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. A total 3,000 patients will be recruited and followed 5 years.

Recruitment information / eligibility
Status Completed
Enrollment 3267
Est. completion date May 28, 2019
Est. primary completion date January 30, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia

Exclusion Criteria:

- Patients who are contraindicated based on the product label

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet
Patients in hemodialysis who have received Fosrenol for hyperphosphatemia.

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 Incidence of adverse drug reactions in subjects who received Fosrenol After Fosrenol administration, up to 8 years
Secondary Timing of onset of common ADRs related to the priority survey items The items are
Gastrointestinal symptoms
Secondary hyperparathyroidism
Hypocalcaemia and decreased blood calcium		 After Fosrenol administration, up to 8 years
Secondary Effect on bones: Alkaline phosphatase over time After Fosrenol administration, up to 8 years
Secondary Effect on bones: Change in bone density After Fosrenol administration, up to 8 years
Secondary Cardiothoracic ratio over time After Fosrenol administration, up to 8 years
Secondary PWV and ABI over time After Fosrenol administration, up to 8 years
Secondary Serum P, albumin-corrected serum Ca and serum intact PTH, and Ca-P product over time After Fosrenol administration, up to 8 years
Secondary Percentage of patients achieving the serum P control goal After Fosrenol administration, up to 8 years
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
Unknown status NCT01245517 - The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient N/A
Completed NCT01252771 - Phosphate Kinetic Modeling 2 Phase 4
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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