Tokyo, April 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061159) titled 'A prospective intervention study to investigate the renal function protective effect of dapagliflozin in kidney transplant recipients' on April 4.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Condition:
Condition - Kidney Transplant Recipients
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effect of dapagliflozin on renal function in kidney transplant patients and evaluate its potential to improve the long-term prognosis of transplanted kidneys
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - oral dapagliflozin
Interventions/Control_2 - without dapagliflozin
Eligibility:
Age-lower limit - 15
years-old
=
Gender - Male and Female
Key inclusion criteria - eGFR 25mL/min/1.73 m2 or more and urine protein 0.2g/gCr or more
Key exclusion criteria - Patients prone to hypoglycemia/dehydration
Patients with malnutrition
Pregnant/nursing women
Active infection (including a history of urinary tract infection)
Immune rejection within the past 6 months
Target Size - 60
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2022 Year 10 Month 01 Day
Date of IRB - 2022 Year 10 Month 01 Day
Anticipated trial start date - 2022 Year 10 Month 01 Day
Last follow-up date - 2026 Year 10 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069542
Disclaimer: Curated by HT Syndication.