Diabetic NephropathyPhase 2NCT02251067
Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients
A Phase 2 study testing VPI-2690B low dose, VPI-2690B medium dose and VPI-2690B high dose in people with Diabetic Nephropathy, run by Vascular Pharmaceuticals, Inc. at 34 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether VPI-2690B Injection is effective in the treatment of diabetic nephropathy. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- VPI-2690B low dose, VPI-2690B medium dose and VPI-2690B high dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Sep 2014to Mar 2017
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- documented diabetic nephropathy in patients with either Type 1 or Type 2 diabetics
- HbA1c of 7.5-10.5%
- eGFR 30-110 mL/min/1.73m2
- stable ACEi/ARB dose regimen
- stable blood pressure
- BMI less than or equal to 45 kg/m2
Who cannot join
- non-diabetic renal disease
- history of solid organ or islet cell transplant
- history of malignancy within previous 5 years
- systemic immunosuppression therapy
- clinically significant liver disease, hepatitis B or C or HIV
- monoclonal antibody treatment within previous year
Show all 9Show fewer
- recent acute renal injury or major surgery
- significant, recent body weight change
- biopsy proven glomerular disease
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States32 sites
Study site
Albany, New York
Study site
Allentown, Pennsylvania
Study site
Asheville, North Carolina
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Cincinnati, Ohio
Study site
Columbus, Georgia
Study site
Cooper City, Florida
Study site
Coral Springs, Florida
Study site
El Paso, Texas
Study site
Flint, Michigan
Study site
Greenville, North Carolina
Study site
Hialeah, Florida
Study site
Idaho Falls, Idaho
Study site
Kansas City, Missouri
Study site
La Mesa, California
Study site
Las Vegas, Nevada
Study site
Little Rock, Arkansas
Study site
Merrillville, Indiana
Study site
Miami, Florida
Study site
Morehead City, North Carolina
Study site
Mount Prospect, Illinois
Study site
Nashville, Tennessee
Study site
Peoria, Illinois
Study site
Riverside, California
Study site
Sacramento, California
Study site
San Antonio, Texas
Study site
St. Petersburg, Florida
Study site
Tustin, California
Study site
Winston-Salem, North Carolina
Study site
Winter Park, Florida
Study site
Wooster, Ohio
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group, Phase 2, Two-Part Adaptive Study to Evaluate the Safety and Efficacy of VPI-2690B Injection in Patients With Nephropathy Due to Diabetes
The purpose of this study is to determine whether VPI-2690B Injection is effective in the treatment of diabetic nephropathy.
- Conditions
- Diabetic Nephropathy
- Being tested
- VPI-2690B low dose, VPI-2690B medium dose, Placebo to match VPI-2690B, VPI-2690B high dose
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPI-2690B low doseDrug
Comparison of different doses of study drug
VPI-2690B medium doseDrug
Comparison of different doses of study drug
Placebo to match VPI-2690BDrug
VPI-2690B high doseDrug
Comparison of different doses of study drug
| Study group | Role | What they receive |
|---|---|---|
| VPI-2690B low dose | Active comparator | 6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks Receives: Drug: VPI-2690B low dose |
| VPI-2690B medium dose | Active comparator | 18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks Receives: Drug: VPI-2690B medium dose |
| Placebo | Placebo comparator | 6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks Receives: Drug: Placebo to match VPI-2690B |
| VPI-2690B high dose | Active comparator | 48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks Receives: Drug: VPI-2690B high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in albuminuria
Measured: 50 weeks
Secondary outcomes (1)
Change from baseline in eGFR
Measured: 50 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vascular Pharmaceuticals Inc Clinical Trial, Study director, Vascular Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251067
- Sponsor's protocol ID
- VPI-CLIN-201-AD
- Status last verified
- Mar 2017
- First submitted
- 24 Sep 2014
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hong Q, Kim H, Cai GY, Chen XM, He JC, Lee K. Modulation of TGF-beta signaling new approaches toward kidney disease and fibrosis therapy. Int J Biol Sci. 2025 Feb 3;21(4):1649-1665. doi: 10.7150/ijbs.101548. eCollection 2025.
PubMed 39990662
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group, Phase 2, Two-Part Adaptive Study to Evaluate the Safety and Efficacy of VPI-2690B Injection in Patients With Nephropathy Due to Diabetes
- ClinicalTrials.gov ID
- NCT02251067
- Acronym / sponsor ID
- VPI-CLIN-201-AD
- Conditions
- Diabetic Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Vascular Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 26 Sep 2014 (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 determine whether VPI-2690B Injection is effective in the treatment of diabetic nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VPI-2690B low dose | Active comparator | Drug: VPI-2690B low dose6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks |
| VPI-2690B medium dose | Active comparator | Drug: VPI-2690B medium dose18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks |
| Placebo | Placebo comparator | Drug: Placebo to match VPI-2690B6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks |
| VPI-2690B high dose | Active comparator | Drug: VPI-2690B high dose48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- documented diabetic nephropathy in patients with either Type 1 or Type 2 diabetics
- HbA1c of 7.5-10.5%
- eGFR 30-110 mL/min/1.73m2
- stable ACEi/ARB dose regimen
- stable blood pressure
Key exclusion criteria (9 listed)
- non-diabetic renal disease
- history of solid organ or islet cell transplant
- history of malignancy within previous 5 years
- systemic immunosuppression therapy
- clinically significant liver disease, hepatitis B or C or HIV
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 |
|---|---|---|
| VPI-2690B low doseComparison of different doses of study drug | Drug | VPI-2690B low dose |
| VPI-2690B medium doseComparison of different doses of study drug | Drug | VPI-2690B medium dose |
| Placebo to match VPI-2690B | Drug | Placebo |
| VPI-2690B high doseComparison of different doses of study drug | Drug | VPI-2690B high dose |
Primary outcome
Change from baseline in albuminuria
Time frame: 50 weeks
1 secondary outcome
Change from baseline in eGFR
Time frame: 50 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 28 Mar 2017.
- Derived from this study: PubMed 39990662Hong Q, Kim H, Cai GY, Chen XM, He JC, Lee K. Modulation of TGF-beta signaling new approaches toward kidney disease and fibrosis therapy. Int J Biol Sci. 2025 Feb 3;21(4):1649-1665. doi: 10.7150/ijbs.101548. eCollection 2025.
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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.
Vascular Pharmaceuticals Inc Clinical Trial study director
Vascular Pharmaceuticals, Inc.
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VPI-2690B low dose, VPI-2690B medium dose and VPI-2690B high dose in people with Diabetic Nephropathy, run by Vascular Pharmaceuticals, Inc. at 34 sites in 2 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 6 inclusion and 9 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Puerto Rico. 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?
Change from baseline in albuminuria (time frame: 50 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02251067, which also lists 1 linked publication.
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 28 Mar 2017.