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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01814917
Other study ID # MCI-196-E15
Secondary ID
Status Terminated
Phase Phase 3
First received March 18, 2013
Last updated May 25, 2015
Start date August 2013
Est. completion date December 2014

Study information

Verified date May 2015
Source Mitsubishi Tanabe Pharma Corporation
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical DevicesTurkey: Ministry of Health
Study type Interventional

Clinical Trial 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).


Description:

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


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 18 Years
Eligibility 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- The subject has been withdrawn from MCI-196-E14, but is eligible to enter this study according to the following rules, as defined in MCI-196-E14: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in serum phosphorus [P] levels above the age-related upper limit of normal(ULN) on two consecutive occasions, and was withdrawn by the Investigator in order to proceed to this study, where flexible dosing with colestilan (MCI-196) is available. Subjects withdrawn from MCI-196-E14 due to hyperphosphataemia may only enter this study after Week 6 of the short-term study, following two consecutive out-of-range P values (one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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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


Locations

Country Name City State
United Kingdom Investigational site London

Sponsors (1)

Lead Sponsor Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
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