Trial Condition(s):

Hyperphosphatemia

Study in chronic kidney disease (CKD) not on dialysis

Bayer Identifier:

14817

ClinicalTrials.gov Identifier:

NCT01110629

EudraCT Number:

Not Available

Study Completed

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
143
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Fosrenol (Lanthanum Carbonate, BAY77-1931)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Wakayama Medical University Hospital

Wakayama, Japan, 641-8510

Status
Completed
 
Locations

Osaka General Medical Center

Osaka, Japan, 558-8558

Status
Completed
 
Locations

Osaka Rosai Hospital

Sakai, Japan, 591-8025

Status
Completed
 
Locations

Osaka Saiseikai Nakatsu Hospital

Osaka, Japan, 530-0012

Status
Completed
 
Locations

Kitano Hospital

Osaka, Japan, 530-8480

Status
Completed
 
Locations

Okayama Saiseikai General Hospital

Okayama, Japan, 700-0013

Status
Completed
 
Locations

Kurashiki Central Hospital

Kurashiki, Japan, 710-8602

Status
Completed
 
Locations

The Jikei University Hospital

Minato-ku, Japan, 105-8471

Status
Completed
 
Locations

Chubu Rosai Hospital

Nagoya, Japan, 455-8530

Status
Completed
 
Locations

Juntendo Tokyo Koto Geriatric Medical Center

Koto, Japan, 136-0075

Status
Completed
 
Locations

Fujisawa City Hospital

Fujisawa, Japan, 251-8550

Status
Completed
 
Locations

Narita Memorial Hospital

Toyohashi, Japan, 441-8021

Status
Completed
 
Locations

Kawashima Hospital

Tokushima, Japan, 770-0011

Status
Completed
 
Locations

Osaka City General Hospital

Osaka, Japan, 534-0021

Status
Completed
 
Locations

NTT Medical Center Tokyo

Shinagawa, Japan, 141-8625

Status
Completed
 
Locations

Musashino Red Cross Hospital

Musashino, Japan, 180-8610

Status
Completed
 
Locations

Shonan Kamakura General Hospital

Kamakura, Japan, 247-8533

Status
Completed
 
Locations

Kameda Clinic

Kamogawa, Japan, 296-0041

Status
Completed
 
Locations

Kainan Hospital

Yatomi, Japan, 498-8502

Status
Completed
 
Locations

Nagoya Daini Red Cross Hospital

Nagoya, Japan, 466-8650

Status
Completed
 
Locations

Kyushu Medical Center

Fukuoka, Japan, 810-8563

Status
Completed
 
Locations

Kyoto Medical Center

Kyoto, Japan, 612-8555

Status
Completed
 
Locations

Beppu Medical Center

Beppu, Japan, 874-0011

Status
Completed
 
Locations

Oita Medical Center

Oita, Japan, 870-0263

Status
Completed
 
Locations

Nagoya Medical Center

Nagoya, Japan, 460-0001

Status
Completed
 
Locations

Tokyo Medical Center

Meguro-ku, Japan, 152-8902

Status
Completed
 
Locations

Shizuoka Tokushukai Hospital

Shizuoka, Japan, 421-0193

Status
Completed
 
Locations

Social Insurance Chukyo Hospital

Nagoya, Japan, 457-8510

Status
Terminated
 
Locations

Tosei General Hospital

Seto, Japan, 489-8642

Status
Completed
 
Locations

Fukuoka University Hospital

Fukuoka, Japan, 814-0180

Status
Terminated
 
Locations

Saga-Ken Medical Centre Koseikan

Saga, Japan, 840-0054

Status
Completed
 
Locations

Hokkaido Medical Center

Sapporo, Japan, 063-0005

Status
Completed
 
Locations

Kimitsu Chuo Hospital

Kisarazu, Japan, 292-8535

Status
Completed
 
Locations

Kokura Memorial Hospital

Kitakyushu, Japan, 802-8555

Status
Completed
 
Locations

National Fukuoka-Higashi Medical Center

Koga, Japan, 811-3195

Status
Completed
 
Locations

Hyogo Prefectural Amagasaki Hospital

Amagasaki, Japan, 660-0828

Status
Completed
 
Locations

Saiseikai Yokohamashi Nanbu Hospital

Yokohama, Japan, 234-8503

Status
Completed
 
Locations

Saiseikai Yahata General Hospital

Kitakyushu, Japan, 805-0050

Status
Completed
 
Locations

Yokohama City Minato Red Cross Hospital

Yokohama, Japan, 231-8682

Status
Completed
 
Locations

Anjo Kosei Hospital

Anjo, Japan, 446-8602

Status
Completed
 

Trial Design