Long-term Study in Chronic Kidney Disease (Extension From Study 14817)
This study has been completed.
Sponsor:
Bayer
Collaborator:
Shire plc.
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01187628
First received: August 23, 2010
Last updated: April 8, 2013
Last verified: April 2013
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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
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: | Head Medical Development Japan, Bayer Yakuhin Ltd. |
| ClinicalTrials.gov Identifier: | NCT01187628 History of Changes |
| Other Study ID Numbers: | 15074 |
| Study First Received: | August 23, 2010 |
| Last Updated: | April 8, 2013 |
| 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 Hyperphosphatemia Renal Insufficiency, Chronic Kidney Failure, Chronic |
Urologic Diseases Phosphorus Metabolism Disorders Metabolic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on June 18, 2013