Long-term Study in Chronic Kidney Disease (Extension From Study 14817)

This study has been completed.
Sponsor:
Collaborator:
Shire plc.
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01187628
First received: August 23, 2010
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

The objective of this study is to investigate the safety and the effect on reduction of serum phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study.


Condition Intervention Phase
Hyperphosphatemia
Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Long-term Extension Study of Lanthanum Carbonate 750 to 2,250 mg in Hyperphosphatemia in Patients With Chronic Kidney Disease Not on Dialysis (52 Weeks Extension From Study 14817)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Incidence of treatment emergent adverse events [ Time Frame: baseline to Week 60 ] [ Designated as safety issue: Yes ]

Enrollment: 123
Study Start Date: September 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931)
Daily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have completed the 8-week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study by the investigator (including those who plan to be on dialysis during the long-term extension study).

Exclusion Criteria:

  • Patients with any other conditions that the investigator defines as not appropriate to be enrolled in the study
  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: NCT01187628

Locations
Japan
Anjo, Aichi, Japan, 446-8602
Nagoya, Aichi, Japan, 455-8530
Nagoya, Aichi, Japan, 460-0001
Nagoya, Aichi, Japan, 466-8650
Nagoya, Aichi, Japan, 457-8510
Seto, Aichi, Japan, 489-8642
Toyohashi, Aichi, Japan, 441-8021
Yatomi, Aichi, Japan, 498-8502
Kamogawa, Chiba, Japan, 296-0041
Kisarazu, Chiba, Japan, 292-8535
Kitakyushu, Fukuoka, Japan, 805-0050
Kitakyushu, Fukuoka, Japan, 802-0001
Koga, Fukuoka, Japan, 811-3195
Sapporo, Hokkaido, Japan, 063-0005
Amagasaki, Hyogo, Japan, 660-0828
Fujisawa, Kanagawa, Japan, 251-8550
Kamakura, Kanagawa, Japan, 247-8533
Yokohama, Kanagawa, Japan, 231-8682
Yokohama, Kanagawa, Japan, 234-8503
Beppu, Oita, Japan, 874-0011
Kurashiki, Okayama, Japan, 710-8602
Sakai, Osaka, Japan, 591-8025
Koto, Tokyo, Japan, 136-0075
Meguro-ku, Tokyo, Japan, 152-8902
Minato-ku, Tokyo, Japan, 105-8471
Musashino, Tokyo, Japan, 180-8610
Shinagawa, Tokyo, Japan, 141-8625
Fukuoka, Japan, 810-8563
Fukuoka, Japan, 814-0180
Kyoto, Japan, 612-8555
Oita, Japan, 870-0263
Okayama, Japan, 700-0013
Osaka, Japan, 534-0021
Osaka, Japan, 530-0012
Osaka, Japan, 558-8558
Osaka, Japan, 530-8480
Saga, Japan, 840-0054
Shizuoka, Japan, 421-0193
Tokushima, Japan, 770-0011
Wakayama, Japan, 641-8510
Sponsors and Collaborators
Bayer
Shire plc.
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01187628     History of Changes
Other Study ID Numbers: 15074
Study First Received: August 23, 2010
Last Updated: April 2, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Long-term study in Chronic Kidney Disease
Lanthanum Carbonate

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 29, 2014