Diabetic NephropathyPhase 2NCT01756703
A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria
A Phase 2 study testing MT-3995 Low and MT-3995 High in people with Diabetic Nephropathy, run by Tanabe Pharma Corporation at 43 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- MT-3995 Low and MT-3995 High
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 43 sitesin 5 countries
- Study dates
- Nov 2012to Aug 2014
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with Type II diabetic nephropathy, who have been treated with angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
- Glycosylated haemoglobin (HbA1c) ≤10.5%
- An estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m^2
- Subject with albuminuria
Who cannot join
- History of Type I diabetes, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- Serum potassium level <3.5 or >5.0 mmol/L
- Subjects who had acute kidney injury (AKI) within 3 months prior to baseline or have undergone renal dialysis at any time prior to randomisation
- Subjects with a history of renal transplant
- Subjects with clinically significant hypotension
Trial locations and contacts
43 sites in 5 countries.
43 sites in 5 countries
Romania12 sites
Investigational site
Bacau
Investigational site
Baia Mare
Investigational site
Brăila
Investigational site
Brasov
Investigational site
Bucharest
Investigational site
Cluj-Napoca
Investigational site
Iași
Investigational site
Oradea
Investigational site
Ploieşti
Investigational site
Satu Mare
Investigational site
Târgu Mureş
Investigational site
Timișoara
Hungary10 sites
Investigational site
Baja
Investigational site
Budapest
Investigational site
Debrecen
Investigational site
Eger
Investigational site
Kistelek
Investigational site
Komárom
Investigational site
Pécs
Investigational site
Szigetvár
Investigational site
Szikszó
Investigational site
Zalaegerszeg
Bulgaria9 sites
Investigational site
Blagoevgrad
Investigational site
Burgas
Investigational site
Byala
Investigational site
Golenci
Investigational site
Pazardzhik
Investigational site
Plovdiv
Investigational site
Rousse
Investigational site
Sofia
Investigational site
Varna
Slovakia9 sites
Investigational site
Banská Bystrica
Investigational site
Bardejov
Investigational site
Bratislava
Investigational site
Lučenec
Investigational site
Martin
Investigational site
Nitra
Investigational site
Šahy
Investigational site
Štúrovo
Investigational site
Žilina
Lithuania3 sites
Investigational site
Kaunas
Investigational site
Klaipėda
Investigational site
Vilnius
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect on Urine Albumin-to-Creatinine Ratio (UACR), Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of MT-3995 as Add-on Therapy to ACE-I or ARB in Type II Diabetic Nephropathy Subjects With Albuminuria and an eGFR ≥60 mL/Min/1.73m^2
The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria
- Conditions
- Diabetic Nephropathy
- Being tested
- MT-3995 Low, MT-3995 High, Placebo
- Keywords
- Diabetic Nephropathy
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-3995 LowDrug
MT-3995 Low dose for 8 weeks
MT-3995 HighDrug
MT-3995 High dose for 8 weeks
PlaceboDrug
Placebo for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| MT-3995 Low group | Experimental | Not described Receives: Drug: MT-3995 Low |
| MT-3995 High group | Experimental | Not described Receives: Drug: MT-3995 High |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.
Measured: up to 8 weeks
Frequency and nature of treatment-emergent adverse events and serious adverse events.
Measured: up to 16 weeks
Secondary outcomes (3)
Percentage change from baseline in UACR compared to placebo
Measured: up to 8 weeks
Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group.
Measured: up to 8 weeks
Plasma concentrations of MT-3995 and its major metabolite
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 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
- NCT01756703
- Sponsor's protocol ID
- MT-3995-E06
- Status last verified
- Feb 2015
- First submitted
- 20 Dec 2012
- Last updated
- 9 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect on Urine Albumin-to-Creatinine Ratio (UACR), Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of MT-3995 as Add-on Therapy to ACE-I or ARB in Type II Diabetic Nephropathy Subjects With Albuminuria and an eGFR ≥60 mL/Min/1.73m^2
- ClinicalTrials.gov ID
- NCT01756703
- Acronym / sponsor ID
- MT-3995-E06
- Conditions
- Diabetic Nephropathy
- Keywords
- Diabetic Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 27 Dec 2012 (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 purpose of this study is to evaluate pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MT-3995 Low group | Experimental | Drug: MT-3995 Low |
| MT-3995 High group | Experimental | Drug: MT-3995 High |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with Type II diabetic nephropathy, who have been treated with angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
- Glycosylated haemoglobin (HbA1c) ≤10.5%
- An estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m^2
- Subject with albuminuria
Key exclusion criteria (5 listed)
- History of Type I diabetes, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- Serum potassium level <3.5 or >5.0 mmol/L
- Subjects who had acute kidney injury (AKI) within 3 months prior to baseline or have undergone renal dialysis at any time prior to randomisation
- Subjects with a history of renal transplant
- Subjects with clinically significant hypotension
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 |
|---|---|---|
| MT-3995 LowMT-3995 Low dose for 8 weeks | Drug | MT-3995 Low group |
| MT-3995 HighMT-3995 High dose for 8 weeks | Drug | MT-3995 High group |
| PlaceboPlacebo for 8 weeks | Drug | Placebo group |
Primary outcome
Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.
Time frame: up to 8 weeks
Frequency and nature of treatment-emergent adverse events and serious adverse events.
Time frame: up to 16 weeks
3 secondary outcomes
Percentage change from baseline in UACR compared to placebo
Time frame: up to 8 weeks
Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group.
Time frame: up to 8 weeks
Plasma concentrations of MT-3995 and its major metabolite
Time frame: up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 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.
43 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT-3995 Low and MT-3995 High in people with Diabetic Nephropathy, run by Tanabe Pharma Corporation at 43 sites in 5 countries.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Romania, Hungary, Bulgaria, Slovakia, Lithuania. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 change from baseline in Urine albumin-to-creatinine ratio (UACR) within group. (time frame: up to 8 weeks). The study lists 2 primary outcomes in all. 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 9 Feb 2015.