Diabetic NephropathiesNCT04705506
Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification
A study testing Gemigliptin in people with Diabetic Nephropathies, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 3 sites in Thailand.
Trial summary
Dipeptidyl peptidase-4 (DPP-4) inhibitors improve glycemic control and contain pleiotropic actions on kidney injury, albuminuria and vascular inflammation especially in animal models. We plan to evaluate the efficacy of potent DPP4-inhibitors (gemigliptin) in response to these aspects in diabetic nephropathy patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- Gemigliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 3 sitesThailand
- Study dates
- 5 Feb 2017to 1 Mar 2019
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CKD stage 1-3 (eGFR 15-60 ml/min/1.73mL)
- Non-insulin dependent diabetes mellitus , blood glucose level 30-250 mg/dL
- Had clinical features compatible with diabetic nephropathy (urine micro albuminuria > 30 g/g creatinine or has evidence of diabetic retinopathy
Who cannot join
- History of allergy to DPP4-inhibitor
- Concurrent infectious disease
- Inflammatory diseases
- Post kidney transplantation
- Receiving cinacalcet, bisphosphonate ,previously treated with DPP4-Inhibitors and sodium-glucose cotransporter-2 inhibitor (SGLT2-i).
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Faculty of Medicine ,Vajira Hospital
Bangkok, 10300
2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand
Bangkok, 10400
Department of Medicine,Police General Hospital,Thailand
Bangkok, 10500
About this study
Official title: Effect of Gemigliptin on Biomarkers of Kidney Injury and Vascular Calcification in Diabetic Nephropathy: A Randomized Controlled Trial
Dipeptidyl peptidase-4 (DPP-4) inhibitors improve glycemic control and contain pleiotropic actions on kidney injury, albuminuria and vascular inflammation especially in animal models. We plan to evaluate the efficacy of potent DPP4-inhibitors (gemigliptin) in response to these aspects in diabetic nephropathy patients.
Read the detailed description
This is a multi-center, prospective, randomized, placebo-controlled trial. A total of 201 participants were enrolled and randomly assigned to gemigliptin 50 mg daily and standard care of diabetes mellitus for 6 months. The changes of coronary calcium score (CAC score), cardio-ankle vascular index (CAVI), estimated glomerular filtration rate (GFR), markers of vascular calcification and markers of tubular renal injury were evaluated at baseline and 6 months.
- Conditions
- Diabetic Nephropathies
- Being tested
- Gemigliptin
- Keywords
- Gemigliptin, Diabetic Nephropathy, Acute Kidney Injury, Vascular Calcification
- Medical subject headings
- Diabetic Nephropathies, Acute Kidney Injury, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemigliptinDrug
Also called Treatment group
We collected baseline data from all participants for demographic characteristics,comorbid conditions and biochemistry indexes.The biomarkers for vascular calcification and renal injury were collected.Baseline CAC score and CAVI were done.The patients then were randomized into 2 groups: Group 1 received gemigliptin 50 mg /day for 6 months in addition to standard treatment ,Group 2 will have standard treatment for diabetes mellitus (DM) and chronic kidney disease (CKD).The patients will be followed up every eight weeks.Fasting plasma glucose ,BUN creatinine and 24 hour urine protein were measured at each study visit.Patients were scheduled for follow-up visits at months 2,4,and 6.After 6 months ,all the blood tests,CAC score and CAVI will be done again.
| Study group | Role | What they receive |
|---|---|---|
| Gemigliptin group | Experimental | The participants will receive gemigliptin 50 mg daily Receives: Drug: Gemigliptin |
| Control | Placebo comparator | The control received standard care of diabetes Receives: Drug: Gemigliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of renal injury
urine NGAL/Cr,urine Kim-1/Cr,urine LFABP/Cr (pg/mL)
Measured: 6 months
Markers of vascular calcification
serum bone alkaline phosphatase(pg/mL),osteopontin (pg/mL)
Measured: 6 months
Markers of renal injury
Protienuria (mg/day)
Measured: 6 months
Markers of renal injury
eGFR (mL/min/1.73m2)
Measured: 6 months
Markers of vascular calcification
Reactive oxygen species (ng/mL)
Measured: 6 months
Markers of vascular calcification
CAVI,CAC score(unit) ,CAVI normal less than8 ,CAC score normal less than 100
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start5 Feb 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
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 NephropathiesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, prospective, randomized, placebo-controlled trial
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Investigators
- Thananda Trakarnvanich, M.D., Principal investigator, Navamindradhiraj University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705506
- Sponsor's protocol ID
- 186/60
- Status last verified
- Jan 2021
- First submitted
- 9 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Trakarnvanich T, Satirapoj B, Suraamornkul S, Chirananthavat T, Sanpatchayapong A, Claimon T. Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition on Biomarkers of Kidney Injury and Vascular Calcification in Diabetic Kidney Disease: A Randomized Controlled Trial. J Diabetes Res. 2021 Oct 16;2021:7382620. doi: 10.1155/2021/7382620. eCollection 2021.
PubMed 34697593
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gemigliptin on Biomarkers of Kidney Injury and Vascular Calcification in Diabetic Nephropathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04705506
- Acronym / sponsor ID
- 186/60
- Conditions
- Diabetic Nephropathies
- Keywords
- Gemigliptin, Diabetic Nephropathy, Acute Kidney Injury, Vascular Calcification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira HospitalOther government
- Study start
- 5 Feb 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 12 Jan 2021 (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.
Dipeptidyl peptidase-4 (DPP-4) inhibitors improve glycemic control and contain pleiotropic actions on kidney injury, albuminuria and vascular inflammation especially in animal models. We plan to evaluate the efficacy of potent DPP4-inhibitors (gemigliptin) in response to these aspects in diabetic nephropathy patients.
Detailed description
This is a multi-center, prospective, randomized, placebo-controlled trial. A total of 201 participants were enrolled and randomly assigned to gemigliptin 50 mg daily and standard care of diabetes mellitus for 6 months. The changes of coronary calcium score (CAC score), cardio-ankle vascular index (CAVI), estimated glomerular filtration rate (GFR), markers of vascular calcification and markers of tubular renal injury were evaluated at baseline and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-center, prospective, randomized, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Gemigliptin group | Experimental | Drug: GemigliptinThe participants will receive gemigliptin 50 mg daily |
| Control | Placebo comparator | Drug: GemigliptinThe control received standard care of diabetes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with CKD stage 1-3 (eGFR 15-60 ml/min/1.73mL)
- Non-insulin dependent diabetes mellitus , blood glucose level 30-250 mg/dL
- Had clinical features compatible with diabetic nephropathy (urine micro albuminuria > 30 g/g creatinine or has evidence of diabetic retinopathy
Key exclusion criteria (5 listed)
- History of allergy to DPP4-inhibitor
- Concurrent infectious disease
- Inflammatory diseases
- Post kidney transplantation
- Receiving cinacalcet, bisphosphonate ,previously treated with DPP4-Inhibitors and sodium-glucose cotransporter-2 inhibitor (SGLT2-i).
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 |
|---|---|---|
| GemigliptinAlso: Treatment groupWe collected baseline data from all participants for demographic characteristics,comorbid conditions and biochemistry indexes.The biomarkers for vascular calcification and renal injury were collected.Baseline CAC score and CAVI were done.The patients then were randomized into 2 groups: Group 1 received gemigliptin 50 mg /day for 6 months in addition to standard treatment ,Group 2 will have standard treatment for diabetes mellitus (DM) and chronic kidney disease (CKD).The patients will be followed up every eight weeks.Fasting plasma glucose ,BUN creatinine and 24 hour urine protein were measured at each study visit.Patients were scheduled for follow-up visits at months 2,4,and 6.After 6 months ,all the blood tests,CAC score and CAVI will be done again. | Drug | Control, Gemigliptin group |
Primary outcome
Markers of renal injury
Time frame: 6 months
urine NGAL/Cr,urine Kim-1/Cr,urine LFABP/Cr (pg/mL)
Markers of vascular calcification
Time frame: 6 months
serum bone alkaline phosphatase(pg/mL),osteopontin (pg/mL)
Markers of renal injury
Time frame: 6 months
Protienuria (mg/day)
Markers of renal injury
Time frame: 6 months
eGFR (mL/min/1.73m2)
Markers of vascular calcification
Time frame: 6 months
Reactive oxygen species (ng/mL)
Markers of vascular calcification
Time frame: 6 months
CAVI,CAC score(unit) ,CAVI normal less than8 ,CAC score normal less than 100
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 14 Jan 2021.
- Derived from this study: PubMed 34697593Trakarnvanich T, Satirapoj B, Suraamornkul S, Chirananthavat T, Sanpatchayapong A, Claimon T. Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition on Biomarkers of Kidney Injury and Vascular Calcification in Diabetic Kidney Disease: A Randomized Controlled Trial. J Diabetes Res. 2021 Oct 16;2021:7382620. doi: 10.1155/2021/7382620. eCollection 2021.
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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.
Thananda Trakarnvanich, M.D. principal investigator
Navamindradhiraj University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gemigliptin in people with Diabetic Nephropathies, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 3 sites in Thailand.
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 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 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. 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.
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?
Markers of renal injury (time frame: 6 months). The study lists 6 primary outcomes in all. 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 NCT04705506, 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 14 Jan 2021.