Chronic Kidney DiseasePhase 3NCT01818687
Safety and Tolerability Study of MCI-196
A Phase 3 study testing colestilan in people with Chronic Kidney Disease and Not on Dialysis, run by Tanabe Pharma Corporation at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Chronic Kidney Disease, Not on Dialysis, Hyperphosphatemia
- What is being tested?
- colestilan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
This study has been terminated because of insufficient patient recruitment. There were no safety concerns.
- Conditions
- Chronic Kidney Disease, Not on Dialysis, Hyperphosphatemia, Paediatric
- Being tested
- colestilan
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colestilanDrug
Also called BindRen
body surface area equivalent (BSAeq) 3 g/day, 6 g/day, 9 g/day, 12 g/day or 15 g/day
| Study group | Role | What they receive |
|---|---|---|
| MCI-196 (Flexible dose) | Experimental | MCI-196 BSA eq 3g, 6g, 9g, 12g or 15g Receives: Drug: colestilan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who, due to hyperphosphataemia, require rescue treatment and/or discontinuation of therapy with colestilan.
Measured: 17 weeks
Secondary outcomes (2)
Incidence of TEAEs of hypercalcaemia and hypocalcaemia
Measured: 17 weeks
Laboratory safety assessments
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: This study has been terminated because of insufficient patient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818687
- Sponsor's protocol ID
- MCI-196-E16
- Status last verified
- May 2015
- First submitted
- 18 Mar 2013
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01818687
- Acronym / sponsor ID
- MCI-196-E16
- Conditions
- Chronic Kidney Disease, Not on Dialysis, Hyperphosphatemia, Paediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study has been terminated because of insufficient patient recruitment.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study has been terminated because of insufficient patient recruitment. There were no safety concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCI-196 (Flexible dose) | Experimental | Drug: colestilanMCI-196 BSA eq 3g, 6g, 9g, 12g or 15g |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (7 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colestilanAlso: BindRenbody surface area equivalent (BSAeq) 3 g/day, 6 g/day, 9 g/day, 12 g/day or 15 g/day | Drug | MCI-196 (Flexible dose) |
Primary outcome
Percentage of subjects who, due to hyperphosphataemia, require rescue treatment and/or discontinuation of therapy with colestilan.
Time frame: 17 weeks
2 secondary outcomes
Incidence of TEAEs of hypercalcaemia and hypocalcaemia
Time frame: 17 weeks
Laboratory safety assessments
Time frame: 17 weeks
Results and safety
The study was stopped early (reason given: This study has been terminated because of insufficient patient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing colestilan in people with Chronic Kidney Disease and Not on Dialysis, run by Tanabe Pharma Corporation at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study has been terminated because of insufficient patient recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who, due to hyperphosphataemia, require rescue treatment and/or discontinuation of therapy with colestilan. (time frame: 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.