Safety and Tolerability Study of MCI-196

NCT01818687 | Terminated Phase 3 DMC

• 1 other identifier: MCI-196-E16
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease; Not on Dialysis; Hyperphosphatemia; Paediatric

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects who, due to hyperphosphataemia, require rescue treatment and/or discontinuation of therapy with colestilan.

  17 weeks

Secondary Outcomes (2)

• Incidence of TEAEs of hypercalcaemia and hypocalcaemia

  17 weeks

• Laboratory safety assessments

  17 weeks

Study Arms (1)

MCI-196 (Flexible dose)

EXPERIMENTAL

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

Drug: colestilan

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)

Eligibility Criteria

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

You may qualify if:

• 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).
• 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.
• 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.

You may not qualify if:

• The subject has been diagnosed with hypocholesterolaemia (i.e., cholesterol levels below age-related normal ranges, per local practices)
• 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 \[i.e, serum P and Ca levels\]
• The subject was treated with a combination of two or more phosphate binders within one month prior to screening

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 26, 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)