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CompletedNCT01518387Updated Mar 14, 2016

Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients

A Phase 3 interventional study of Lanthanum Carbonate (BAY77-1931) in Hyperphosphatemia, sponsored by Bayer. Completed at 11 sites in Japan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-03-14.

Sponsored by Bayer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
43
Allocation
Not applicable
Ages
20 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.

02

Conditions studied

  • Hyperphosphatemia

Keywords

  • Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis
03

In context

Hyperphosphatemia

152 studies on the registry are indexed under Hyperphosphatemia; 11 are open to participants now.

This study's enrollment of 43 is below the median of 105 across 127 interventional studies indexed under Hyperphosphatemia.

Browse Hyperphosphatemia studies →

Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.

Browse Bayer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Serum phosphate levels: >5.0 mg/dL and \<11.0 mg/dL 2 weeks after the initiation of the washout period
  • Out-patient
  • Undergoing CAPD for at least previous 3 consecutive months

Exclusion criteria

Exclusion Criteria:

  • Who may not enable to continue CAPD
  • Serum phosphate levels of >=10.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
  • Corrected serum calcium level of \<7.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
  • Serum intact PTH (Parathyroid) of >=1000 pg/mL at the start of the washout period
  • Pregnant woman, or lactating mother
  • Significant gastrointestinal disorders including known acute peptic ulcer
  • Liver dysfunction
  • History of cardiovascular or cerebrovascular diseases
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Arm 1

    750-2250mg/day, tid, 8 weeks

    Drug: Lanthanum Carbonate (BAY77-1931)

06

What researchers measure

Primary outcomes

  1. Change from baseline in serum phosphate levels at the end of the treatment period

    Time frame: Baseline to Week 8

Secondary outcomes

  1. Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement

    Time frame: Week 8

  2. Serum calcium level corrected by serum albumin level at the end of the treatment period

    Time frame: Week 8

  3. Serum calcium x phosphate product at the end of the treatment period

    Time frame: Week 8

  4. Serum intact-PTH (Parathyroid) levels at the end of the treatment period

    Time frame: Week 8

  5. Safety variables will be summarized using descriptive statistics based on adverse events collection

    Time frame: 8 weeks

07

Study locations

11 sites
  • Fukuoka, Fukuoka 815-0082, Japan
  • Gifu, Gifu 500-8717, Japan
  • Hiroshima, Hiroshima 730-8655, Japan
  • Asahikawa, Hokkaido 070-0030, Japan
  • Kamakura, Kanagawa 247-0072, Japan
  • Yokosuka, Kanagawa 238-0011, Japan
  • Ōsaki, Miyagi 989-6117, Japan
  • Sendai, Miyagi 981-0912, Japan
  • Okayama, Okayama-ken 700-0013, Japan
  • Tokushima, Tokushima 770-0011, Japan
  • Meguro-ku, Tokyo 153-0061, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01518387
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Jan 26, 2012
Start date
Jan 2006
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Mar 14, 2016

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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