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NCT Number: NCT04705506

Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification

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.

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Key information

Conditions

Diabetic Nephropathies Acute Kidney Injury Calcinosis Calcium Metabolism Disorders Diabetes Complications Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Calcification

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand, Bangkok, Thailand

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

gemigliptin

Drug

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.

Other names: Treatment group

Primary outcomes

  1. Markers of renal injury

    Time frame: 6 months

    urine NGAL/Cr,urine Kim-1/Cr,urine LFABP/Cr (pg/mL)

  2. Markers of vascular calcification

    Time frame: 6 months

    serum bone alkaline phosphatase(pg/mL),osteopontin (pg/mL)

  3. Markers of renal injury

    Time frame: 6 months

    Protienuria (mg/day)

  4. Markers of renal injury

    Time frame: 6 months

    eGFR (mL/min/1.73m2)

  5. Markers of vascular calcification

    Time frame: 6 months

    Reactive oxygen species (ng/mL)

  6. Markers of vascular calcification

    Time frame: 6 months

    CAVI,CAC score(unit) ,CAVI normal less than8 ,CAC score normal less than 100

Sponsors and collaborators

Lead sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 12, 2021
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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