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Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate

Primary Purpose

Hyperphosphatemia

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Lanthanum carbonate (BAY77-1931)

Calcium carbonate

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and <11.0 mg/dL at 1 week after the initiation of the washout period.
Out-patient
Undergoing hemodialysis three times per week for at least previous 3 consecutive months

Exclusion Criteria:

Pre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after
Corrected serum calcium level of <7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 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
Requiring treatment for hypothyroidism

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

750-2250mg/day, tid (three times a day), 8 weeks

1500-4500mg/day, tid, 8 weeks

Outcomes

Primary Outcome Measures

Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period

Presence/absence of incidence of hypercalcemia up to 8 weeks

Secondary Outcome Measures

Number of participants achieving target PSPL and time to achievement

Serum calcium x phosphate product at the end of the double-blind treatment period

Serum intact-PTH (Parathyroid) levels

Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period

Number of participants achieving the target serum calcium levels

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

Full Information

NCT ID

NCT01514851

First Posted

January 18, 2012

Last Updated

June 7, 2012

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01514851

Brief Title

Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate

Official Title

Phase III Double-blind Comparative Study of BAY 77 1931 (Lanthanum Carbonate) With a Calcium Carbonate in Patients With Hyperphosphatemia Undergoing Hemodialysis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

May 2006 (Actual)

Study Completion Date

May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperphosphatemia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

259 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

750-2250mg/day, tid (three times a day), 8 weeks

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Description

1500-4500mg/day, tid, 8 weeks

Intervention Type

Drug

Intervention Name(s)

Lanthanum carbonate (BAY77-1931)

Intervention Type

Drug

Intervention Name(s)

Calcium carbonate

Primary Outcome Measure Information:

Title

Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period

Time Frame

baseline to week 8

Title

Presence/absence of incidence of hypercalcemia up to 8 weeks

Time Frame

up to 8 weeks

Secondary Outcome Measure Information:

Title

Number of participants achieving target PSPL and time to achievement

Time Frame

up to 8 weeks

Title

Serum calcium x phosphate product at the end of the double-blind treatment period

Time Frame

Week 8

Title

Serum intact-PTH (Parathyroid) levels

Time Frame

Week 8

Title

Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period

Time Frame

Week 8

Title

Number of participants achieving the target serum calcium levels

Time Frame

Week 8

Title

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

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and <11.0 mg/dL at 1 week after the initiation of the washout period. Out-patient Undergoing hemodialysis three times per week for at least previous 3 consecutive months Exclusion Criteria: Pre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after Corrected serum calcium level of <7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 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 Requiring treatment for hypothyroidism

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Toyohashi

State/Province

Aichi

ZIP/Postal Code

441-8023

Country

Japan

City

Yatomi

State/Province

Aichi

ZIP/Postal Code

498-0006

Country

Japan

City

Asahi

State/Province

Chiba

ZIP/Postal Code

289-2511

Country

Japan

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-0084

Country

Japan

City

Matsudo

State/Province

Chiba

ZIP/Postal Code

271-0077

Country

Japan

City

Narita

State/Province

Chiba

ZIP/Postal Code

286-0041

Country

Japan

City

Kurume

State/Province

Fukuoka

ZIP/Postal Code

830-8522

Country

Japan

City

Kurume

State/Province

Fukuoka

ZIP/Postal Code

830-8543

Country

Japan

City

Isesaki

State/Province

Gunma

ZIP/Postal Code

379-2211

Country

Japan

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

658-0084

Country

Japan

City

Mito

State/Province

Ibaraki

ZIP/Postal Code

310-0844

Country

Japan

City

Tsuchiura

State/Province

Ibaraki

ZIP/Postal Code

300-0053

Country

Japan

City

Takamatsu

State/Province

Kagawa

ZIP/Postal Code

761-8024

Country

Japan

City

Osaki

State/Province

Miyagi

ZIP/Postal Code

989-6117

Country

Japan

City

Sendai

State/Province

Miyagi

ZIP/Postal Code

981-0912

Country

Japan

City

Suita

State/Province

Osaka

ZIP/Postal Code

564-0053

Country

Japan

City

Fuji

State/Province

Shizuoka

ZIP/Postal Code

417-0056

Country

Japan

City

Hamamatsu

State/Province

Shizuoka

ZIP/Postal Code

430-0903

Country

Japan

City

Arakawa-ku

State/Province

Tokyo

ZIP/Postal Code

116-0003

Country

Japan

City

Kodaira

State/Province

Tokyo

ZIP/Postal Code

187-0001

Country

Japan

City

Nerima-ku

State/Province

Tokyo

ZIP/Postal Code

176-0023

Country

Japan

City

Shibuya-ku

State/Province

Tokyo

ZIP/Postal Code

151-0053

Country

Japan

City

Shinjyuku-ku

State/Province

Tokyo

ZIP/Postal Code

160-0023

Country

Japan

City

Chiba

ZIP/Postal Code

261-0011

Country

Japan

City

Hiroshima

ZIP/Postal Code

730-0811

Country

Japan

City

Kochi

ZIP/Postal Code

780-0066

Country

Japan

City

Okayama

ZIP/Postal Code

701-0202

Country

Japan

City

Saitama

ZIP/Postal Code

330-0854

Country

Japan

City

Saitama

ZIP/Postal Code

330-0856

Country

Japan

City

Saitama

ZIP/Postal Code

337-0043

Country

Japan

City

Tokushima

ZIP/Postal Code

770-0011

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate

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