check_circleStudy Completed

Hyperphosphatemia

Bayer Identifier:

14817

ClinicalTrials.gov Identifier:

NCT01110629

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study in chronic kidney disease (CKD) not on dialysis

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.

Key Participants Requirements

Sex

Both

Age

20 Years
  • - 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)
  • - 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
June 2010 - November 2011
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Fosrenol (Lanthanum Carbonate, BAY77-1931)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Wakayama Medical University HospitalWakayama, 641-8510, Japan
Completed
Osaka General Medical CenterOsaka, 558-8558, Japan
Completed
Osaka Rosai HospitalSakai, 591-8025, Japan
Completed
Osaka Saiseikai Nakatsu HospitalOsaka, 530-0012, Japan
Completed
Kitano HospitalOsaka, 530-8480, Japan
Completed
Okayama Saiseikai General HospitalOkayama, 700-0013, Japan
Completed
Kurashiki Central HospitalKurashiki, 710-8602, Japan
Completed
The Jikei University HospitalMinato-ku, 105-8471, Japan
Completed
Chubu Rosai HospitalNagoya, 455-8530, Japan
Completed
Juntendo Tokyo Koto Geriatric Medical CenterKoto, 136-0075, Japan
Completed
Fujisawa City HospitalFujisawa, 251-8550, Japan
Completed
Narita Memorial HospitalToyohashi, 441-8021, Japan
Completed
Kawashima HospitalTokushima, 770-0011, Japan
Completed
Osaka City General HospitalOsaka, 534-0021, Japan
Completed
NTT Medical Center TokyoShinagawa, 141-8625, Japan
Completed
Musashino Red Cross HospitalMusashino, 180-8610, Japan
Completed
Shonan Kamakura General HospitalKamakura, 247-8533, Japan
Completed
Kameda ClinicKamogawa, 296-0041, Japan
Completed
Kainan HospitalYatomi, 498-8502, Japan
Completed
Nagoya Daini Red Cross HospitalNagoya, 466-8650, Japan
Completed
Kyushu Medical CenterFukuoka, 810-8563, Japan
Completed
Kyoto Medical CenterKyoto, 612-8555, Japan
Completed
Beppu Medical CenterBeppu, 874-0011, Japan
Completed
Oita Medical CenterOita, 870-0263, Japan
Completed
Nagoya Medical CenterNagoya, 460-0001, Japan
Completed
Tokyo Medical CenterMeguro-ku, 152-8902, Japan
Completed
Shizuoka Tokushukai HospitalShizuoka, 421-0193, Japan
Terminated
Social Insurance Chukyo HospitalNagoya, 457-8510, Japan
Completed
Tosei General HospitalSeto, 489-8642, Japan
Terminated
Fukuoka University HospitalFukuoka, 814-0180, Japan
Completed
Saga-Ken Medical Centre KoseikanSaga, 840-0054, Japan
Completed
Hokkaido Medical CenterSapporo, 063-0005, Japan
Completed
Kimitsu Chuo HospitalKisarazu, 292-8535, Japan
Completed
Kokura Memorial HospitalKitakyushu, 802-8555, Japan
Completed
National Fukuoka-Higashi Medical CenterKoga, 811-3195, Japan
Completed
Hyogo Prefectural Amagasaki HospitalAmagasaki, 660-0828, Japan
Completed
Saiseikai Yokohamashi Nanbu HospitalYokohama, 234-8503, Japan
Completed
Saiseikai Yahata General HospitalKitakyushu, 805-0050, Japan
Completed
Yokohama City Minato Red Cross HospitalYokohama, 231-8682, Japan
Completed
Anjo Kosei HospitalAnjo, 446-8602, Japan

Primary Outcome

  • The change from baseline in serum phosphate concentrations
    date_rangeTime Frame:
    Week 8
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Achievement of target serum phosphate level (2.7 to 4.6 mg/dL)
    date_rangeTime Frame:
    Week 0, Week 2, Week 4, Week 6, Week 8
    enhanced_encryption
    Safety Issue:
    no
  • Change in serum Calcium x Phosphor product
    date_rangeTime Frame:
    Week 0, Week 2, Week 4, Week 6, Week 8
    enhanced_encryption
    Safety Issue:
    No
  • Serum intact PTH level
    date_rangeTime Frame:
    Week 0, Week 2, Week 4, Week 6, Week 8
    enhanced_encryption
    Safety Issue:
    no
  • Phosphate excretion in urine
    date_rangeTime Frame:
    Week 0, Week 4, Week 8
    enhanced_encryption
    Safety Issue:
    no

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

Additional Information

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