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Study in Chronic Kidney Disease (CKD) Not on Dialysis

Primary Purpose

Hyperphosphatemia

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Fosrenol (Lanthanum Carbonate, BAY77-1931)

Placebo

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring Chronic kidney disease not on dialysis, Lanthanum carbonate

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

The change from baseline in serum phosphate concentrations

Secondary Outcome Measures

Achievement of target serum phosphate level (2.7 to 4.6 mg/dL)

Change in serum Calcium x Phosphor product

Serum intact PTH level

Phosphate excretion in urine

Full Information

NCT ID

NCT01110629

First Posted

April 23, 2010

Last Updated

October 12, 2014

Sponsor

Bayer

Collaborators

Shire

1. Study Identification

Unique Protocol Identification Number

NCT01110629

Brief Title

Study in Chronic Kidney Disease (CKD) Not on Dialysis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

Collaborators

Shire

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Hyperphosphatemia

Keywords

Chronic kidney disease not on dialysis, Lanthanum carbonate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

143 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Fosrenol (Lanthanum Carbonate, BAY77-1931)

Intervention Description

Daily dose: 750-2250mg 3 times a dayfor 8 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

daily dose: 3 tablets TID for 8 weeks.

Primary Outcome Measure Information:

Title

The change from baseline in serum phosphate concentrations

Time Frame

Week 8

Secondary Outcome Measure Information:

Title

Achievement of target serum phosphate level (2.7 to 4.6 mg/dL)

Time Frame

Week 0, Week 2, Week 4, Week 6, Week 8

Title

Change in serum Calcium x Phosphor product

Time Frame

Week 0, Week 2, Week 4, Week 6, Week 8

Title

Serum intact PTH level

Time Frame

Week 0, Week 2, Week 4, Week 6, Week 8

Title

Phosphate excretion in urine

Time Frame

Week 0, Week 4, Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Anjo

State/Province

Aichi

ZIP/Postal Code

446-8602

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

455-8530

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

457-8510

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

460-0001

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

466-8650

Country

Japan

City

Seto

State/Province

Aichi

ZIP/Postal Code

489-8642

Country

Japan

City

Toyohashi

State/Province

Aichi

ZIP/Postal Code

441-8021

Country

Japan

City

Yatomi

State/Province

Aichi

ZIP/Postal Code

498-8502

Country

Japan

City

Kamogawa

State/Province

Chiba

ZIP/Postal Code

296-0041

Country

Japan

City

Kisarazu

State/Province

Chiba

ZIP/Postal Code

292-8535

Country

Japan

City

Kitakyushu

State/Province

Fukuoka

ZIP/Postal Code

802-8555

Country

Japan

City

Kitakyushu

State/Province

Fukuoka

ZIP/Postal Code

805-0050

Country

Japan

City

Koga

State/Province

Fukuoka

ZIP/Postal Code

811-3195

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

063-0005

Country

Japan

City

Amagasaki

State/Province

Hyogo

ZIP/Postal Code

660-0828

Country

Japan

City

Fujisawa

State/Province

Kanagawa

ZIP/Postal Code

251-8550

Country

Japan

City

Kamakura

State/Province

Kanagawa

ZIP/Postal Code

247-8533

Country

Japan

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

231-8682

Country

Japan

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

234-8503

Country

Japan

City

Beppu

State/Province

Oita

ZIP/Postal Code

874-0011

Country

Japan

City

Kurashiki

State/Province

Okayama

ZIP/Postal Code

710-8602

Country

Japan

City

Sakai

State/Province

Osaka

ZIP/Postal Code

591-8025

Country

Japan

City

Koto

State/Province

Tokyo

ZIP/Postal Code

136-0075

Country

Japan

City

Meguro-ku

State/Province

Tokyo

ZIP/Postal Code

152-8902

Country

Japan

City

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

105-8471

Country

Japan

City

Musashino

State/Province

Tokyo

ZIP/Postal Code

180-8610

Country

Japan

City

Shinagawa

State/Province

Tokyo

ZIP/Postal Code

141-8625

Country

Japan

City

Fukuoka

ZIP/Postal Code

810-8563

Country

Japan

City

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

City

Kyoto

ZIP/Postal Code

612-8555

Country

Japan

City

Oita

ZIP/Postal Code

870-0263

Country

Japan

City

Okayama

ZIP/Postal Code

700-0013

Country

Japan

City

Osaka

ZIP/Postal Code

530-0012

Country

Japan

City

Osaka

ZIP/Postal Code

530-8480

Country

Japan

City

Osaka

ZIP/Postal Code

534-0021

Country

Japan

City

Osaka

ZIP/Postal Code

558-8558

Country

Japan

City

Saga

ZIP/Postal Code

840-0054

Country

Japan

City

Shizuoka

ZIP/Postal Code

421-0193

Country

Japan

City

Tokushima

ZIP/Postal Code

770-0011

Country

Japan

City

Wakayama

ZIP/Postal Code

641-8510

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

25079863

Citation

Takahara Y, Matsuda Y, Takahashi S, Shigematsu T; Lanthanum Carbonate Study Group. Efficacy and safety of lanthanum carbonate in pre-dialysis CKD patients with hyperphosphatemia: a randomized trial. Clin Nephrol. 2014 Sep;82(3):181-90. doi: 10.5414/cn108269.

Results Reference

derived

Learn more about this trial

Study in Chronic Kidney Disease (CKD) Not on Dialysis

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