Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification

Diabetic Nephropathies Clinical Trial

Official title:

Effect of Gemigliptin on Biomarkers of Kidney Injury and Vascular Calcification in Diabetic Nephropathy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04705506
• Other study ID #: 186/60
• Status: Completed
• Phase: N/A
• Start date: February 5, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: January 2021
• Source: Bangkok Metropolitan Administration Medical College and Vajira Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Calcinosis
• Diabetic Nephropathies
• Kidney Diseases
• Vascular Calcification

Intervention

Drug:
• Gemigliptin
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.

Locations

Country	Name	City	State
Thailand	2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand	Bangkok
Thailand	Department of Medicine,Police General Hospital,Thailand	Bangkok
Thailand	Faculty of Medicine ,Vajira Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Bangkok Metropolitan Administration Medical College and Vajira Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Markers of renal injury	urine NGAL/Cr,urine Kim-1/Cr,urine LFABP/Cr (pg/mL)	6 months
Primary	Markers of vascular calcification	serum bone alkaline phosphatase(pg/mL),osteopontin (pg/mL)	6 months
Primary	Markers of renal injury	Protienuria (mg/day)	6 months
Primary	Markers of renal injury	eGFR (mL/min/1.73m2)	6 months
Primary	Markers of vascular calcification	Reactive oxygen species (ng/mL)	6 months
Primary	Markers of vascular calcification	CAVI,CAC score(unit) ,CAVI normal less than8 ,CAC score normal less than 100	6 months