Study in Chronic Kidney Disease (CKD) Not on Dialysis
This study has been completed.
Sponsor:
Bayer
Collaborator:
Shire Development LLC
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01110629
First received: April 23, 2010
Last updated: October 11, 2012
Last verified: October 2012
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Purpose
The objective of this study is to investigate the efficacy and safety of lanthanum carbonate 750 to 2,250 mg in Japanese Chronic Kidney Disease Stage 3, 4 and 5 subjects not on dialysis.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperphosphatemia |
Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lanthanum Carbonate 750 to 2250 mg in Patients With Chronic Kidney Disease Not on Dialysis Who Develop Hyperphosphatemia |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- The change from baseline in serum phosphate concentrations [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Achievement of target serum phosphate level (2.7 to 4.6 mg/dL) [ Time Frame: Week 0, Week 2, Week 4, Week 6, Week 8 ] [ Designated as safety issue: No ]
- Change in serum Calcium x Phosphor product [ Time Frame: Week 0, Week 2, Week 4, Week 6, Week 8 ] [ Designated as safety issue: No ]
- Serum intact PTH level [ Time Frame: Week 0, Week 2, Week 4, Week 6, Week 8 ] [ Designated as safety issue: No ]
- Phosphate excretion in urine [ Time Frame: Week 0, Week 4, Week 8 ] [ Designated as safety issue: No ]
| Enrollment: | 143 |
| Study Start Date: | June 2010 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931)
Daily dose: 750-2250mg 3 times a dayfor 8 weeks.
|
| Placebo Comparator: Arm 2 |
Drug: Placebo
daily dose: 3 tablets TID for 8 weeks.
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female patients aged 20 years or above at the time of informed consent
- Chronic Kidney Disease patients with Epidermal growth factor receptor (eGFR) under 60 ml/min/1.73m2 (stage 3, 4 and 5) who have not been on dialysis
- Patients who had been in the care of a physician for Chronic Kidney Disease for >2 months and was not expected to begin dialysis for at least 4 months
- Patients with serum phosphate levels 5.6 mg/dL to 11.0 mg/dL at Week -4 (Visit 1) or Week -2 (Visit 2)
Exclusion Criteria:
- Patients with hypocalcemia or hypercalcemia (corrected serum calcium level of < 7.0 mg/dL or >/- 11.0 mg/dL) at Week -2 (Visit 2).
- Significant renal impairments
- Had acute renal failure within 3 months of Run-in period
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110629
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, 247-0072 | |
| 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 Development LLC
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: | NCT01110629 History of Changes |
| Other Study ID Numbers: | 14817 |
| Study First Received: | April 23, 2010 |
| Last Updated: | October 11, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Bayer:
|
Chronic kidney disease not on dialysis 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 May 16, 2013