Safety and Tolerability Study of MCI-196

Chronic Kidney Disease Clinical Trial

Official title:

A Multi-centre, Open-label Study Evaluating the Safety and Tolerability of Colestilan (MCI-196) in Paediatric Subjects With Chronic Kidney Disease Stages 3b to 5 and With Hyperphosphataemia Not on Dialysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01818687
• Other study ID #: MCI-196-E16
• 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 objective of this study is to assess the safety and tolerability of colestilan (MCI-196) in paediatric subjects (aged 2 years to <18 years) with CKD stages 3b to 5, diagnosed with hyperphosphataemia, who are not on dialysis.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• 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:

• Children aged 2 years to <18 years with CKD stages 3b to 5, not on dialysis (stage 3b is defined as a glomerular filtration rate below 45 mL/min/1.73 m²).

• The subject has a documented diagnosis of hyperphosphataemia, as demonstrated by serum phosphorus (P) levels above the age-related upper limit of normal (ULN) (Kidney Disease Outcomes Quality Initiative [KDOQI] Clinical Practice Guidelines for Nutrition in Children with CKD updated 2008).

• The subject is on a stable P diet at baseline (as judged by the Investigator).

Inclusion criteria for subjects not currently treated with phosphate binders:

• The subject, with serum P not controlled despite being on an appropriate P diet, must demonstrate serum P levels >1.5 standard deviation (SD) above the KDOQI 2008 age-related mean value at any time during the screening period. Such subjects do not require wash-out and should proceed to baseline for the next visit if additional screening visits are not required.

Baseline inclusion criteria for subjects treated with phosphate binders:

• The subject must enter the wash-out period, during which he/she must demonstrate serum P levels >1.5 SD above the KDOQI 2008 age-related mean value at any time during the wash-out period (after stopping phosphate binders), and;

• The subject must demonstrate an increase in serum P levels by at least 10% above the pre wash-out level (after stopping phosphate binders).

Note: should a subject fail to meet any of the above criteria, the subject is permitted to be re-screened once after an interval of at least three months.

Exclusion Criteria:

• The subject has been diagnosed with hypocholesterolaemia (i.e., cholesterol levels below age-related normal ranges, per local practices)

• The subject has current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose him/her 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 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 cannot stop treatment (prescription or over the-counter) of any of the following orally taken medications during the wash-out period: any product containing calcium (Ca), magnesium (Mg), aluminium compounds, sevelamer, lanthanum, ketosteril

• The subject is receiving immunosuppressant treatment for any medical condition at the baseline visit or is expected to receive such treatment during the course of the study

• The subject is considered as unstable on his/her current treatment for CKD within one month prior to screening (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 Ca levels]

Exclusion criteria for subjects treated with phosphate binders:

• The subject was treated with a combination of two or more phosphate binders within one month prior to screening

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperphosphatemia
• Kidney Diseases
• Not on Dialysis
• Paediatric
• Renal Insufficiency, Chronic

Intervention

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

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	Percentage of subjects who, due to hyperphosphataemia, require rescue treatment and/or discontinuation of therapy with colestilan.		17 weeks	Yes
Secondary	Incidence of TEAEs of hypercalcaemia and hypocalcaemia		17 weeks	Yes
Secondary	Laboratory safety assessments		17 weeks	Yes