Trial Condition(s):
Hyperphosphatemia
Study in chronic kidney disease (CKD) not on dialysis
Bayer Identifier:
14817
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Wakayama Medical University Hospital Wakayama, Japan, 641-8510 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka General Medical Center Osaka, Japan, 558-8558 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka Rosai Hospital Sakai, Japan, 591-8025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka Saiseikai Nakatsu Hospital Osaka, Japan, 530-0012 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kitano Hospital Osaka, Japan, 530-8480 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Okayama Saiseikai General Hospital Okayama, Japan, 700-0013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kurashiki Central Hospital Kurashiki, Japan, 710-8602 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Jikei University Hospital Minato-ku, Japan, 105-8471 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chubu Rosai Hospital Nagoya, Japan, 455-8530 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Juntendo Tokyo Koto Geriatric Medical Center Koto, Japan, 136-0075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fujisawa City Hospital Fujisawa, Japan, 251-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Narita Memorial Hospital Toyohashi, Japan, 441-8021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kawashima Hospital Tokushima, Japan, 770-0011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka City General Hospital Osaka, Japan, 534-0021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NTT Medical Center Tokyo Shinagawa, Japan, 141-8625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Musashino Red Cross Hospital Musashino, Japan, 180-8610 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shonan Kamakura General Hospital Kamakura, Japan, 247-8533 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kameda Clinic Kamogawa, Japan, 296-0041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kainan Hospital Yatomi, Japan, 498-8502 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nagoya Daini Red Cross Hospital Nagoya, Japan, 466-8650 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyushu Medical Center Fukuoka, Japan, 810-8563 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyoto Medical Center Kyoto, Japan, 612-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Beppu Medical Center Beppu, Japan, 874-0011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oita Medical Center Oita, Japan, 870-0263 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nagoya Medical Center Nagoya, Japan, 460-0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokyo Medical Center Meguro-ku, Japan, 152-8902 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shizuoka Tokushukai Hospital Shizuoka, Japan, 421-0193 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Social Insurance Chukyo Hospital Nagoya, Japan, 457-8510 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tosei General Hospital Seto, Japan, 489-8642 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fukuoka University Hospital Fukuoka, Japan, 814-0180 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saga-Ken Medical Centre Koseikan Saga, Japan, 840-0054 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hokkaido Medical Center Sapporo, Japan, 063-0005 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kimitsu Chuo Hospital Kisarazu, Japan, 292-8535 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kokura Memorial Hospital Kitakyushu, Japan, 802-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Fukuoka-Higashi Medical Center Koga, Japan, 811-3195 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hyogo Prefectural Amagasaki Hospital Amagasaki, Japan, 660-0828 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saiseikai Yokohamashi Nanbu Hospital Yokohama, Japan, 234-8503 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saiseikai Yahata General Hospital Kitakyushu, Japan, 805-0050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yokohama City Minato Red Cross Hospital Yokohama, Japan, 231-8682 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Anjo Kosei Hospital Anjo, Japan, 446-8602 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- The change from baseline in serum phosphate concentrationsTimeframe: Week 8
Secondary Outcome
- Achievement of target serum phosphate level (2.7 to 4.6 mg/dL)Timeframe: Week 0, Week 2, Week 4, Week 6, Week 8
- Change in serum Calcium x Phosphor productTimeframe: Week 0, Week 2, Week 4, Week 6, Week 8
- Serum intact PTH levelTimeframe: Week 0, Week 2, Week 4, Week 6, Week 8
- Phosphate excretion in urineTimeframe: Week 0, Week 4, Week 8
Additional Information
Copyright © Bayer
Powered by
