Diabetic NephropathyPhase 2NCT02410499
Efficacy and Safety of Weekly Subcutaneous MLN1202 in Improving Diabetic Nephropathy in Participants With Macroalbuminuria
A Phase 2 study testing MLN1202 in people with Diabetic Nephropathy, run by Takeda.
Trial summary
The purpose of this study is to characterize the effects of 85 days treatment with MLN1202 on urinary albumin-to-creatinine ratio (UACR) in participants with type 2 diabetes, advanced kidney disease/diabetic nephropathy (DN) and macro-albuminuria (UACR>300 mg/g) based on average of 3 consecutive first morning voids… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- MLN1202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2015to 17 Nov 2015
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In the opinion of the investigator, the participant is capable of giving informed consent to enter the trial, including understanding and complying with protocol requirements.
- The participant or, when applicable, (eg, where the subject is capable of giving verbal informed consent to enter the trial but cannot physically sign a written, informed consent form), the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- At the time of Screening the participant is male or female and aged 18-90 years inclusive at first dose of study medication.
- Was previously diagnosed with type 2 diabetes mellitus per American Diabetes Association criteria.
- Has an estimated glomerular filtration rate (eGFR) based on serum creatinine (eGFR, determined by Modification of Diet in Renal Disease [MDRD] equation) of 25-59 mL/min/1.73 m(2) at Screening.
- Has been on a stable dose of angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) for 8 weeks prior to Screening.
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- Has residual albuminuria despite stable treatment with an ACE inhibitor or an ARB for at least 8 weeks prior to Screening (albumin:creatinine ratio [ACR] of > 300 mg/g creatinine, inclusive at Screening).
- Has glycosylated hemoglobin (HbA1c) less than or equal to 10.5% at screening.
- If a subject is regularly using dipeptidyl peptidase-4 inhibitor (DPP-4i) or sodium-glucose cotransporter 2 inhibitor (SGLT2i) to treat diabetes, he/she has been on a stable dose and regimen within 2 months prior to Screening.
- All participants who are not surgically sterile or post-menopausal, or whose partners are not surgically-sterile or postmenopausal, must use two effective birth control methods or abstain from intercourse during this study.
Who cannot join
- Has received any investigational compound within 90 days prior to Screening.
- Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
- Is taking any combination of dual renin-angiotensin system (RAS) inhibition (such as an ACE inhibitor and an ARB or an ACE inhibitor and a mineralocorticoid receptor antagonist).
- Has type 1 diabetes mellitus or a history of ketoacidosis.
- Has poorly-controlled blood pressure (systolic blood pressure >160 or diastolic blood pressure >110, with blood pressure measured in the seated position after at least 5 minutes of rest) at Screening and Day 1.
- Has received dialysis within 3 months of Screening.
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- Has infectious diseases or leg ulcers at Screening (all per discretion of Principal Investigator [PI]).
- Has severe concurrent disease which, in the judgment of the investigator, would interfere significantly with the assessments of safety and efficacy during this study.
- Has known infection with human immunodeficiency virus (HIV), or a positive test for Hepatitis B, Hepatitis C, or tuberculosis (TB) at Screening. Subjects who have a positive TB skin test at Screening must rule out active or latent tuberculosis documented by chest x-ray in order to be considered eligible for study participation.
- Has used long-term immune suppressants, steroid therapy (except for topical use or inhalation), chronic use of non-steroidal anti-inflammatory drug (NSAIDs), cyclooxygenase type 2 (COX-2) inhibitors within 2 weeks prior to Screening. Short-term use is defined as a duration of ≤4 weeks of continuous use.
- In the judgment of the principal investigator, participants who are likely to be non-compliant or uncooperative during the study.
- Has known non-diabetic kidney disease (such as autosomal dominant polycystic kidney disease (ADPCKD), Immunoglobulin A (IgA) nephropathy, focal segmental glomerulosclerosis, or obstructive uropathy). Hypertensive nephrosclerosis superimposed on diabetic kidney disease is acceptable.
- Had a previous renal transplant.
- Has hypersensitivity to other monoclonal antibodies (mAb) or to any component of the formulation of MLN1202.
- Has history of malignancy within the previous 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
- Is symptomatic with dysuria, and has a positive urine culture at screening.
- If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period and for 56 days (8weeks) afterwards.
- If male, the subject intends to donate sperm during the course of this study or for 12 weeks thereafter.
About this study
Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Proof of Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Weekly Subcutaneous MLN1202, in Improving Diabetic Nephropathy in Subjects With Macroalbuminuria
The purpose of this study is to characterize the effects of 85 days treatment with MLN1202 on urinary albumin-to-creatinine ratio (UACR) in participants with type 2 diabetes, advanced kidney disease/diabetic nephropathy (DN) and macro-albuminuria (UACR>300 mg/g) based on average of 3 consecutive first morning voids sample collection.
Read the detailed description
The drug being tested in this study is called MLN1202. MLN1202 is being tested to treat people who have diabetes with macroalbuminuria. This study will look at the urinary albumin-to-creatinine ratio in people who take MLN1202.
The study will enroll approximately 156 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- MLN1202 75 mg subcutaneous (SC) injection
- MLN1202 105 mg SC injection
- MLN1202 150 mg SC injection
- Placebo matching MLN1202 SC injection (dummy inactive solution) - this is a solution that looks like the study drug but has no active ingredient
All participants will receive a loading dose of placebo or MLN1202 on Day 1 followed by once-weekly injections of the study medication they were randomized to receive.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is 5 months. Participants will make multiple visits to the clinic, plus a final visit 5 weeks after the last dose of study drug for a follow-up assessment.
- Conditions
- Diabetic Nephropathy
- Being tested
- MLN1202 Placebo, MLN1202
- Keywords
- Drug therapy
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLN1202 PlaceboDrug
MLN1202 placebo-matching solution for SC injection
MLN1202Drug
MLN1202 solution for SC injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | MLN1202 placebo-matching solution, subcutaneous injection (SC), once, on Day 1 (loading dose), followed by MLN1202 placebo-matching solution, SC, once, weekly, on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Receives: Drug: MLN1202 Placebo |
| MLN1202 75 mg | Experimental | MLN1202 450 mg, solution, SC injection, once, on Day 1 (loading dose), followed by MLN1202 75 mg, solution, SC, once, weekly, on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Receives: Drug: MLN1202 |
| MLN1202 105 mg | Experimental | MLN1202 450 mg, solution, SC injection, once, on Day 1 (loading dose), followed by MLN1202 105 mg, solution, SC, once, weekly, on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Receives: Drug: MLN1202 |
| MLN1202 150 mg | Experimental | MLN1202 450 mg, solution, SC injection, once, on Day 1 (loading dose), followed by MLN1202 150 mg, solution, SC, once, weekly, on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Receives: Drug: MLN1202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) at Day 85
UACR will be calculated using the geometric mean of 3 consecutive days first in the morning urine voids. First morning void is defined as a void upon awakening and before beginning daily activities.
Measured: Baseline and Day 85
Secondary outcomes (2)
Change from Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Over Time
For Days 29 and 57 UACR will be evaluated from a single first morning void. For Days 85 and 113 UACR will be calculated using the geometric mean of 3 consecutive days first in the morning urine voids. First morning void is defined as a void upon awakening and before beginning daily activities.
Measured: Baseline and Days 29, 57, 85, and 113
Change from Baseline in Urinary Protein:Creatinine Ratio (UPCR) Over Time
For Days 29 and 57 UPAR will be evaluated from a single first morning void. For Days 85 and 113 UPCR will be calculated using the geometric mean of 3 consecutive days first in the morning urine voids. First morning void is defined as a void upon awakening and before beginning daily activities.
Measured: Baseline and Days 29, 57, 85, and 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study start20 May 2015
- Primary completion17 Nov 2015
- Study completion17 Nov 2015
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.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410499
- Sponsor's protocol ID
- MLN1202-2005
- Other IDs
- 2014-005142-21, U1111-1168-1426, 2014
- Status last verified
- Sep 2017
- First submitted
- 2 Apr 2015
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Placebo Controlled, Proof of Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Weekly Subcutaneous MLN1202, in Improving Diabetic Nephropathy in Subjects With Macroalbuminuria
- ClinicalTrials.gov ID
- NCT02410499
- Acronym / sponsor ID
- MLN1202-2005
- Conditions
- Diabetic Nephropathy
- Keywords
- Drug therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 20 May 2015 (actual)
- Primary completion
- 17 Nov 2015 (actual)
- Study completion
- 17 Nov 2015 (actual)
- First posted
- 7 Apr 2015 (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 characterize the effects of 85 days treatment with MLN1202 on urinary albumin-to-creatinine ratio (UACR) in participants with type 2 diabetes, advanced kidney disease/diabetic nephropathy (DN) and macro-albuminuria (UACR>300 mg/g) based on average of 3 consecutive first morning voids sample collection.
Detailed description
The drug being tested in this study is called MLN1202. MLN1202 is being tested to treat people who have diabetes with macroalbuminuria. This study will look at the urinary albumin-to-creatinine ratio in people who take MLN1202.
The study will enroll approximately 156 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- MLN1202 75 mg subcutaneous (SC) injection
- MLN1202 105 mg SC injection
- MLN1202 150 mg SC injection
- Placebo matching MLN1202 SC injection (dummy inactive solution) - this is a solution that looks like the study drug but has no active ingredient
All participants will receive a loading dose of placebo or MLN1202 on Day 1 followed by once-weekly injections of the study medication they were randomized to receive.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is 5 months. Participants will make multiple visits to the clinic, plus a final visit 5 weeks after the last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: MLN1202 PlaceboMLN1202 placebo-matching solution, subcutaneous injection (SC), once, on Day 1 (loading dose), followed by MLN1202 placebo-matching solution, SC, once, weekly, on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
| MLN1202 75 mg | Experimental | Drug: MLN1202MLN1202 450 mg, solution, SC injection, once, on Day 1 (loading dose), followed by MLN1202 75 mg, solution, SC, once, weekly, on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
| MLN1202 105 mg | Experimental | Drug: MLN1202MLN1202 450 mg, solution, SC injection, once, on Day 1 (loading dose), followed by MLN1202 105 mg, solution, SC, once, weekly, on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
| MLN1202 150 mg | Experimental | Drug: MLN1202MLN1202 450 mg, solution, SC injection, once, on Day 1 (loading dose), followed by MLN1202 150 mg, solution, SC, once, weekly, on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- In the opinion of the investigator, the participant is capable of giving informed consent to enter the trial, including understanding and complying with protocol requirements.
- The participant or, when applicable, (eg, where the subject is capable of giving verbal informed consent to enter the trial but cannot physically sign a written, informed consent form), the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- At the time of Screening the participant is male or female and aged 18-90 years inclusive at first dose of study medication.
- Was previously diagnosed with type 2 diabetes mellitus per American Diabetes Association criteria.
- Has an estimated glomerular filtration rate (eGFR) based on serum creatinine (eGFR, determined by Modification of Diet in Renal Disease [MDRD] equation) of 25-59 mL/min/1.73 m(2) at Screening.
Key exclusion criteria (18 listed)
- Has received any investigational compound within 90 days prior to Screening.
- Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
- Is taking any combination of dual renin-angiotensin system (RAS) inhibition (such as an ACE inhibitor and an ARB or an ACE inhibitor and a mineralocorticoid receptor antagonist).
- Has type 1 diabetes mellitus or a history of ketoacidosis.
- Has poorly-controlled blood pressure (systolic blood pressure >160 or diastolic blood pressure >110, with blood pressure measured in the seated position after at least 5 minutes of rest) at Screening and Day 1.
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 |
|---|---|---|
| MLN1202 PlaceboMLN1202 placebo-matching solution for SC injection | Drug | Placebo |
| MLN1202MLN1202 solution for SC injection | Drug | MLN1202 105 mg, MLN1202 150 mg, MLN1202 75 mg |
Primary outcome
Change from Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) at Day 85
Time frame: Baseline and Day 85
UACR will be calculated using the geometric mean of 3 consecutive days first in the morning urine voids. First morning void is defined as a void upon awakening and before beginning daily activities.
2 secondary outcomes
Change from Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Over Time
Time frame: Baseline and Days 29, 57, 85, and 113
Change from Baseline in Urinary Protein:Creatinine Ratio (UPCR) Over Time
Time frame: Baseline and Days 29, 57, 85, and 113
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
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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.
Medical Director Clinical Science study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MLN1202 in people with Diabetic Nephropathy, run by Takeda.
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 10 inclusion and 18 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: withdrawn, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change from Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) at Day 85 (time frame: Baseline and Day 85). 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 25 Sep 2017.