Clinical trial NCT04705506: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Nephropathies
Keywords: Gemigliptin
Diabetic Nephropathy
Acute Kidney Injury
Vascular Calcification
Lead sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital
Sponsor class: OTHER_GOV
First posted: 2021-01-12
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, prospective, randomized, placebo-controlled trial
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Markers of renal injury
timeFrame: 6 months
measure: Markers of vascular calcification
timeFrame: 6 months
measure: Markers of renal injury
timeFrame: 6 months
measure: Markers of renal injury
timeFrame: 6 months
measure: Markers of vascular calcification
timeFrame: 6 months
measure: Markers of vascular calcification
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine ,Vajira Hospital
city: Bangkok
country: Thailand
facility: 2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand
city: Bangkok
country: Thailand
facility: Department of Medicine,Police General Hospital,Thailand
Study officials:
affiliation: Navamindradhiraj University
name: Thananda Trakarnvanich, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.