Diabetic Kidney DiseasePhase 3BENCHNCT03105219
IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease
A Phase 3 study testing Ivabradine in people with Diabetic Kidney Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
To explore the efficacy of Ivabradine for the treatment of microalbuminuria in patients with type 2 diabetes and coronary heart disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Ivabradine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 May 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Type 2 diabetes and coronary heart disease;
- 2. Urinary albumin excretion: 30-500mg/24h;
- 3. Sinus rhythm, and resting heart rate ≥ 70bpm;
Who cannot join
- 1. Renal dysfunction defined as eGFR < 30ml/min/1.73m^2;
- 2. Atrial flutter, and atrial fibrillation;
- 3. Resting heart rate < 70bpm;
- 4. Combined with non-dihydropyridine CCB;
- 5. UAE<30mg/24h, or > 500mg/24h;
- 6. Acute heart failure;
- 7. Low blood pressure (BP<90/50mmHg);
- 8. Acute myocardial infarction (<14 days);
Trial locations and contacts
1 site in 1 country.
About this study
To explore the efficacy of Ivabradine for the treatment of microalbuminuria in patients with type 2 diabetes and coronary heart disease.
Read the detailed description
This is a multi-center, randomized, open-label, investigator-initiated study with a parallel design. Patients with type 2 diabetes and coronary heart disease who are microalbuminuric [urinary albumin excretion (UAE): 30-500 mg/day], will be randomized after informed consent, in a 1:1 ratio to the following treatment groups: Group Α: Ivabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day.
Group Β: Placebo. Urinary albumin excretion (UAE) assessment will be performed before randomization (Day 0), 28-day after randomization (Day 28), and 90-day after randomization (Day 28).
- Conditions
- Diabetic Kidney Disease
- Being tested
- Ivabradine, Sham Comparator
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Ivabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day.
Sham ComparatorOther
Urinary albumin excretion (UAE) assessment will be performed before randomization (Day 0), 28-day after randomization (Day 28), and 90-day after randomization (Day 28).
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine | Experimental | Ivabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day. Receives: Drug: Ivabradine |
| Sham Comparator | Sham comparator | Urinary albumin excretion (UAE) assessment will be performed before randomization (Day 0), 28-day after randomization (Day 28), and 90-day after randomization (Day 28). Receives: Other: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary albumin excretion
Urinary albumin excretion at 3 month
Measured: 3 month
Secondary outcomes (9)
Serum creatinine
Serum creatinine at 3 month
Measured: 3 month
Blood urea nitrogen
Blood urea nitrogen at 3 month
Measured: 3 month
Cyscatin-c
Cyscatin-c at 3 month
Measured: 3 month
Hypersensitive c-reactive protein (hsCRP)
Hypersensitive c-reactive protein (hsCRP) at 3 month
Measured: 3 month
β2-microglobulin
β2-microglobulin at 3 month
Measured: 3 month
Neutrophil gelatinase-associated lipocalin(NGAL)
Neutrophil gelatinase-associated lipocalin(NGAL) at 3 month
Measured: 3 month
Albuminuria and urine creatinine ratio (ACR)
Albuminuria and urine creatinine ratio (ACR) at 3 month
Measured: 3 month
N-acyl-β-D-glucosidase
N-acyl-β-D-glucosidase at 3 month
Measured: 3 month
Retinol binding protein
Retinol binding protein at 3 month
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start1 Jul 2017 (estimated)
- Primary completion30 May 2021 (estimated)
- Study completion30 May 2021 (estimated)
Why it stopped: Shortfall in funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Shaoliang Chen, MD, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105219
- Sponsor's protocol ID
- NFH20170403
- Acronym
- BENCH
- Status last verified
- Nov 2020
- First submitted
- 3 Apr 2017
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT03105219
- Acronym / sponsor ID
- BENCH / NFH20170403
- Conditions
- Diabetic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Shortfall in funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 7 Apr 2017 (actual)
- 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.
To explore the efficacy of Ivabradine for the treatment of microalbuminuria in patients with type 2 diabetes and coronary heart disease.
Detailed description
This is a multi-center, randomized, open-label, investigator-initiated study with a parallel design. Patients with type 2 diabetes and coronary heart disease who are microalbuminuric [urinary albumin excretion (UAE): 30-500 mg/day], will be randomized after informed consent, in a 1:1 ratio to the following treatment groups: Group Α: Ivabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day.
Group Β: Placebo. Urinary albumin excretion (UAE) assessment will be performed before randomization (Day 0), 28-day after randomization (Day 28), and 90-day after randomization (Day 28).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivabradine | Experimental | Drug: IvabradineIvabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day. |
| Sham Comparator | Sham comparator | Other: Sham ComparatorUrinary albumin excretion (UAE) assessment will be performed before randomization (Day 0), 28-day after randomization (Day 28), and 90-day after randomization (Day 28). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Type 2 diabetes and coronary heart disease;
- 2. Urinary albumin excretion: 30-500mg/24h;
- 3. Sinus rhythm, and resting heart rate ≥ 70bpm;
Key exclusion criteria (8 listed)
- 1. Renal dysfunction defined as eGFR < 30ml/min/1.73m^2;
- 2. Atrial flutter, and atrial fibrillation;
- 3. Resting heart rate < 70bpm;
- 4. Combined with non-dihydropyridine CCB;
- 5. UAE<30mg/24h, or > 500mg/24h;
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 |
|---|---|---|
| IvabradineIvabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day. | Drug | Ivabradine |
| Sham ComparatorUrinary albumin excretion (UAE) assessment will be performed before randomization (Day 0), 28-day after randomization (Day 28), and 90-day after randomization (Day 28). | Other | Sham Comparator |
Primary outcome
Urinary albumin excretion
Time frame: 3 month
Urinary albumin excretion at 3 month
9 secondary outcomes
Serum creatinine
Time frame: 3 month
Blood urea nitrogen
Time frame: 3 month
Cyscatin-c
Time frame: 3 month
Hypersensitive c-reactive protein (hsCRP)
Time frame: 3 month
β2-microglobulin
Time frame: 3 month
Neutrophil gelatinase-associated lipocalin(NGAL)
Time frame: 3 month
Albuminuria and urine creatinine ratio (ACR)
Time frame: 3 month
N-acyl-β-D-glucosidase
Time frame: 3 month
Retinol binding protein
Time frame: 3 month
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 9 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Shaoliang Chen, MD study chair
Nanjing First Hospital, Nanjing Medical University
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 Ivabradine in people with Diabetic Kidney Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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 3 inclusion and 8 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 9 Nov 2020. 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 China. 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 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 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?
Urinary albumin excretion (time frame: 3 month). 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 Nov 2020.