search
Back to results

Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification

Primary Purpose

Diabetic Nephropathies

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Gemigliptin
Sponsored by
Bangkok Metropolitan Administration Medical College and Vajira Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathies focused on measuring Gemigliptin, Diabetic Nephropathy, Acute Kidney Injury, Vascular Calcification

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Sites / Locations

  • Faculty of Medicine ,Vajira Hospital
  • 2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand
  • Department of Medicine,Police General Hospital,Thailand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gemigliptin group

Control

Arm Description

The participants will receive gemigliptin 50 mg daily

The control received standard care of diabetes

Outcomes

Primary Outcome Measures

Markers of renal injury
urine NGAL/Cr,urine Kim-1/Cr,urine LFABP/Cr (pg/mL)
Markers of vascular calcification
serum bone alkaline phosphatase(pg/mL),osteopontin (pg/mL)
Markers of renal injury
Protienuria (mg/day)
Markers of renal injury
eGFR (mL/min/1.73m2)
Markers of vascular calcification
Reactive oxygen species (ng/mL)
Markers of vascular calcification
CAVI,CAC score(unit) ,CAVI normal less than8 ,CAC score normal less than 100

Secondary Outcome Measures

Full Information

First Posted
January 9, 2021
Last Updated
January 12, 2021
Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04705506
Brief Title
Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification
Official Title
Effect of Gemigliptin on Biomarkers of Kidney Injury and Vascular Calcification in Diabetic Nephropathy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 5, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies
Keywords
Gemigliptin, Diabetic Nephropathy, Acute Kidney Injury, Vascular Calcification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multi-center, prospective, randomized, placebo-controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemigliptin group
Arm Type
Experimental
Arm Description
The participants will receive gemigliptin 50 mg daily
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The control received standard care of diabetes
Intervention Type
Drug
Intervention Name(s)
Gemigliptin
Other Intervention Name(s)
Treatment group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Markers of renal injury
Description
urine NGAL/Cr,urine Kim-1/Cr,urine LFABP/Cr (pg/mL)
Time Frame
6 months
Title
Markers of vascular calcification
Description
serum bone alkaline phosphatase(pg/mL),osteopontin (pg/mL)
Time Frame
6 months
Title
Markers of renal injury
Description
Protienuria (mg/day)
Time Frame
6 months
Title
Markers of renal injury
Description
eGFR (mL/min/1.73m2)
Time Frame
6 months
Title
Markers of vascular calcification
Description
Reactive oxygen species (ng/mL)
Time Frame
6 months
Title
Markers of vascular calcification
Description
CAVI,CAC score(unit) ,CAVI normal less than8 ,CAC score normal less than 100
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thananda Trakarnvanich, M.D.
Organizational Affiliation
Navamindradhiraj University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine ,Vajira Hospital
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Facility Name
2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Department of Medicine,Police General Hospital,Thailand
City
Bangkok
ZIP/Postal Code
10500
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
34697593
Citation
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.
Results Reference
derived

Learn more about this trial

Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification

We'll reach out to this number within 24 hrs