NCT01518387

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

January 18, 2012

Last Update Submit

March 10, 2016

Conditions

Hyperphosphatemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

    Baseline to Week 8

Secondary Outcomes (5)

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

    Week 8

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

    Week 8

  • Serum calcium x phosphate product at the end of the treatment period

    Week 8

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

    Week 8

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

    8 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL

750-2250mg/day, tid, 8 weeks

Drug: Lanthanum Carbonate (BAY77-1931)

Interventions

Lanthanum Carbonate (BAY77-1931)DRUG
Arm 1

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Fukuoka, Fukuoka, 815-0082, Japan

Location

Unknown Facility

Gifu, Gifu, 500-8717, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, 730-8655, Japan

Location

Unknown Facility

Asahikawa, Hokkaido, 070-0030, Japan

Location

Unknown Facility

Kamakura, Kanagawa, 247-0072, Japan

Location

Unknown Facility

Yokosuka, Kanagawa, 238-0011, Japan

Location

Unknown Facility

Ōsaki, Miyagi, 989-6117, Japan

Location

Unknown Facility

Sendai, Miyagi, 981-0912, Japan

Location

Unknown Facility

Okayama, Okayama-ken, 700-0013, Japan

Location

Unknown Facility

Tokushima, Tokushima, 770-0011, Japan

Location

Unknown Facility

Meguro-ku, Tokyo, 153-0061, Japan

Location

MeSH Terms

Conditions

HyperphosphatemiaKidney Failure, Chronic

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 26, 2012

Study Start

January 1, 2006

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

March 14, 2016

Record last verified: 2016-03

Locations

JP(11)