Chronic Kidney DiseasePhase 3NCT01814917
Long-term Extension Study of MCI-196
A Phase 3 study testing colestilan and CBPB in people with Chronic Kidney Disease and Dialysis, run by Tanabe Pharma Corporation at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- What is being tested?
- colestilan and CBPB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 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
- 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- The subject has been withdrawn from MCI-196-E14, but is eligible to enter this study according to the following rules, as defined in MCI-196-E14: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in serum phosphorus [P] levels above the age-related upper limit of normal(ULN) on two consecutive occasions, and was withdrawn by the Investigator in order to proceed to this study, where flexible dosing with colestilan (MCI-196) is available. Subjects withdrawn from MCI-196-E14 due to hyperphosphataemia may only enter this study after Week 6 of the short-term study, following two consecutive out-of-range P values (one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- Hypercalcaemia: Subjects treated with CBPB and experiencing hypercalcaemia may be withdrawn from the short-term study at the discretion of the Investigator in order to proceed to this study at any time, where flexible dosing with colestilan (MCI-196)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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centre, Flexible Dose, Parallel Group, Open-label, Active Control (Calcium-based Phosphate Binder), Long-term Extension Study Evaluating the Efficacy, Safety and Tolerability of Colestilan (MCI-196) in Paediatric Subjects With Hyperphosphataemia and With Either Chronic Kidney Disease Stage 5 on Dialysis or Chronic Kidney Disease Stages 3b to 5 Not on Dialysis
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).
Read the detailed description
This study has been terminated because of insufficient patient recruitment. There were no safety concerns.
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Paediatric
- Being tested
- colestilan, CBPB
- 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
CBPBDrug
| Study group | Role | What they receive |
|---|---|---|
| MCI-196 (Flexible dose) | Experimental | MCI-196 BSA eq 3g, 6g, 9g, 12g or 15g Receives: Drug: colestilan |
| CBPB | Active comparator | Calcium-based P binder Receives: Drug: CBPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)])
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT01814917
- Sponsor's protocol ID
- MCI-196-E15
- 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, Flexible Dose, Parallel Group, Open-label, Active Control (Calcium-based Phosphate Binder), Long-term Extension Study Evaluating the Efficacy, Safety and Tolerability of Colestilan (MCI-196) in Paediatric Subjects With Hyperphosphataemia and With Either Chronic Kidney Disease Stage 5 on Dialysis or Chronic Kidney Disease Stages 3b to 5 Not on Dialysis
- ClinicalTrials.gov ID
- NCT01814917
- Acronym / sponsor ID
- MCI-196-E15
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Paediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study has been terminated because of insufficient patient recruitment.
- Enrolment
- 6 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
- 20 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 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).
Detailed description
This study has been terminated because of insufficient patient recruitment. There were no safety concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCI-196 (Flexible dose) | Experimental | Drug: colestilanMCI-196 BSA eq 3g, 6g, 9g, 12g or 15g |
| CBPB | Active comparator | Drug: CBPBCalcium-based P binder |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
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) |
| CBPB | Drug | CBPB |
Primary outcome
Proportion of responders (responders are defined as subjects demonstrating serum P levels ≤1.5 SD above the KDOQI 2008 age-related mean value)
Time frame: 52 weeks
Kidney Disease Outcomes Quality Initiative (KDOQI)
2 secondary outcomes
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)
Time frame: 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)])
Time frame: 52 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 and CBPB in people with Chronic Kidney Disease and 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 6 inclusion and 4 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?
Proportion of responders (responders are defined as subjects demonstrating serum P levels ≤1.5 SD above the KDOQI 2008 age-related mean value) (time frame: 52 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.