Long-term Extension Study of MCI-196

NCT01814917 | Terminated Phase 3 DMC

• 1 other identifier: MCI-196-E15
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Kidney Disease; Dialysis; Hyperphosphatemia; Paediatric

Outcome Measures

Primary Outcomes (1)

• 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)

  52 weeks

Secondary Outcomes (2)

• 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)

  52 weeks

• 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)])

  52 weeks

Study Arms (2)

MCI-196 (Flexible dose)

EXPERIMENTAL

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

Drug: colestilan

CBPB

ACTIVE COMPARATOR

Calcium-based P binder

Drug: CBPB

Interventions

colestilan DRUG

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

Also known as: BindRen

MCI-196 (Flexible dose)

CBPB DRUG

CBPB

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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• The subject has been withdrawn from MCI-196-E14, but is eligible to enter this study according to the following rules, as defined in MCI-196-E14: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in serum phosphorus \[P\] levels above the age-related upper limit of normal(ULN) on two consecutive occasions, and was withdrawn by the Investigator in order to proceed to this study, where flexible dosing with colestilan (MCI-196) is available.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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Investigational site

London, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia

Interventions

cholebine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 20, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

GB (1)