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Long-term Extension Study of MCI-196

Primary Purpose

Chronic Kidney Disease, Dialysis, Hyperphosphatemia

Status

Terminated

Phase

Phase 3

Locations

United Kingdom

Study Type

Interventional

Intervention

colestilan

CBPB

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The subject and/or parent(s)/guardian(s) must be capable of providing informed consent, and assent when applicable, in agreement with regional requirements.
The subject has completed either of the short-term studies, MCI-196-E14 or MCI-196-E16

The subject has been withdrawn from MCI-196-E14, but is eligible to enter this study according to the following rules, as defined in MCI-196-E14:
- Hyperphosphataemia: Subjects who experienced hyperphosphataemia, defined as any increase in serum phosphorus [P] levels above the age-related upper limit of normal(ULN) on two consecutive occasions, and was withdrawn by the Investigator in order to proceed to this study, where flexible dosing with colestilan (MCI-196) is available. Subjects withdrawn from MCI-196-E14 due to hyperphosphataemia may only enter this study after Week 6 of the short-term study, following two consecutive out-of-range P values (one obtained at Week 3 and one obtained at Week 6). After Week 6, subjects meeting the above criteria may enter this study at any time (the two consecutive out-of-range P values having been obtained any time after Week 6 from a scheduled or unscheduled visit).
- Hypercalcaemia: Subjects treated with CBPB and experiencing hypercalcaemia may be withdrawn from the short-term study at the discretion of the Investigator in order to proceed to this study at any time, where flexible dosing with colestilan (MCI-196) is available.

Exclusion Criteria:

The subject has current clinically significant medical co-morbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, make the subject unsuitable for inclusion in the study (e.g., the subject currently has or has had a history of seizure disorders, dysphagia, swallowing disorders, predisposition to or current bowel obstruction, ileus or severe gastrointestinal [GI] disorders such as chronic or severe constipation [as judged by the Investigator], intestinal stenosis, intestinal diverticulum, sigmoid colitis, GI ulcers, current or a history of GI bleeding, or major GI tract surgery).
The subject is expected to receive immunosuppressant treatment during the course of the study.
The subject is considered unstable on his/her current treatment for CKD within one month prior to enrolment (e.g., subjects starting treatment with vitamin D or its analogues, or other agents/procedures that may influence bone mineral metabolism [i.e., serum P and calcium (Ca) levels]).
The subject is considered to be non-compliant with study procedures in the opinion of the Investigator.

Sites / Locations

Investigational site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MCI-196 (Flexible dose)

CBPB

Arm Description

MCI-196 BSA eq 3g, 6g, 9g, 12g or 15g

Calcium-based P binder

Outcomes

Primary Outcome Measures

Proportion of responders (responders are defined as subjects demonstrating serum P levels ≤1.5 SD above the KDOQI 2008 age-related mean value)

Kidney Disease Outcomes Quality Initiative (KDOQI)

Secondary Outcome Measures

Mean absolute change in efficacy laboratory parameters (i.e.,P, Ca, Ca P ion product [CaxP], intact parathyroid hormone [iPTH], serum glucose, glycosylated haemoglobin [HbA1c], and uric acid)

Mean percentage change in other efficacy laboratory parameters (i.e., lipid parameters [low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), total cholesterol, and triglycerides (TG)])

Full Information

NCT ID

NCT01814917

First Posted

March 18, 2013

Last Updated

May 25, 2015

Sponsor

Mitsubishi Tanabe Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01814917

Brief Title

Long-term Extension Study of MCI-196

Official Title

A Multi-centre, Flexible Dose, Parallel Group, Open-label, Active Control (Calcium-based Phosphate Binder), Long-term Extension Study Evaluating the Efficacy, Safety and Tolerability of Colestilan (MCI-196) in Paediatric Subjects With Hyperphosphataemia and With Either Chronic Kidney Disease Stage 5 on Dialysis or Chronic Kidney Disease Stages 3b to 5 Not on Dialysis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Terminated

Why Stopped

This study has been terminated because of insufficient patient recruitment.

Study Start Date

August 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The Primary Objectives of this study are to assess the long-term efficacy of treatment with colestilan (MCI-196) (including combination therapy) and to assess the long-term safety of treatment with colestilan (MCI-196) (including combination therapy).

Detailed Description

This study has been terminated because of insufficient patient recruitment. There were no safety concerns.

6. Conditions and Keywords

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

Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Paediatric

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MCI-196 (Flexible dose)

Arm Type

Experimental

Arm Description

MCI-196 BSA eq 3g, 6g, 9g, 12g or 15g

Arm Title

CBPB

Arm Type

Active Comparator

Arm Description

Calcium-based P binder

Intervention Type

Drug

Intervention Name(s)

colestilan

Other Intervention Name(s)

BindRen

Intervention Description

body surface area equivalent (BSAeq) 3 g/day, 6 g/day, 9 g/day, 12 g/day or 15 g/day

Intervention Type

Drug

Intervention Name(s)

CBPB

Primary Outcome Measure Information:

Title

Proportion of responders (responders are defined as subjects demonstrating serum P levels ≤1.5 SD above the KDOQI 2008 age-related mean value)

Description

Kidney Disease Outcomes Quality Initiative (KDOQI)

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Mean absolute change in efficacy laboratory parameters (i.e.,P, Ca, Ca P ion product [CaxP], intact parathyroid hormone [iPTH], serum glucose, glycosylated haemoglobin [HbA1c], and uric acid)

Time Frame

52 weeks

Title

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The subject and/or parent(s)/guardian(s) must be capable of providing informed consent, and assent when applicable, in agreement with regional requirements. The subject has completed either of the short-term studies, MCI-196-E14 or MCI-196-E16 or The subject has been withdrawn from MCI-196-E14, but is eligible to enter this study according to the following rules, as defined in MCI-196-E14: Hyperphosphataemia: Subjects who experienced hyperphosphataemia, defined as any increase in serum phosphorus [P] levels above the age-related upper limit of normal(ULN) on two consecutive occasions, and was withdrawn by the Investigator in order to proceed to this study, where flexible dosing with colestilan (MCI-196) is available. Subjects withdrawn from MCI-196-E14 due to hyperphosphataemia may only enter this study after Week 6 of the short-term study, following two consecutive out-of-range P values (one obtained at Week 3 and one obtained at Week 6). After Week 6, subjects meeting the above criteria may enter this study at any time (the two consecutive out-of-range P values having been obtained any time after Week 6 from a scheduled or unscheduled visit). Hypercalcaemia: Subjects treated with CBPB and experiencing hypercalcaemia may be withdrawn from the short-term study at the discretion of the Investigator in order to proceed to this study at any time, where flexible dosing with colestilan (MCI-196) is available. Exclusion Criteria: The subject has current clinically significant medical co-morbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, make the subject unsuitable for inclusion in the study (e.g., the subject currently has or has had a history of seizure disorders, dysphagia, swallowing disorders, predisposition to or current bowel obstruction, ileus or severe gastrointestinal [GI] disorders such as chronic or severe constipation [as judged by the Investigator], intestinal stenosis, intestinal diverticulum, sigmoid colitis, GI ulcers, current or a history of GI bleeding, or major GI tract surgery). The subject is expected to receive immunosuppressant treatment during the course of the study. The subject is considered unstable on his/her current treatment for CKD within one month prior to enrolment (e.g., subjects starting treatment with vitamin D or its analogues, or other agents/procedures that may influence bone mineral metabolism [i.e., serum P and calcium (Ca) levels]). The subject is considered to be non-compliant with study procedures in the opinion of the Investigator.

Facility Information:

Facility Name

Investigational site

City

London

Country

United Kingdom

12. IPD Sharing Statement

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Long-term Extension Study of MCI-196

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