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临床试验/CTRI/2025/02/080581
CTRI/2025/02/080581尚未招募3 期

A comparison between standard of care treatment and Dapagliflozin added to standard of care treatment in maintenance phase of lupus nephritis patients a randomised controlled trial pilot study

DR MANISH RATHI1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年2月23日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Treatment Response as per KDIGO guidelines, Serum Creatinine , 24hr urine protein

研究概览

简要总结

After getting the informed consent, the patients with Lupus Nephritis will be screened as per the inclusion and exclusion criteria . After fulfilment of the inclusion criteria, patient will be randomised into either arm. All  patients in the both arm will be receiving maintenance therapy with Mycophenolate Mofetil 1 to 2 gm per day with oral prednisolone 0.5 to 1mg per kg per day tapered over several months. The treatment arm will receive Dapagliflozin 10mg per day in addition to Mycophenolate Mofetil and Steroids. The patients are followed up every monthly for first 6 months. At the end of first 6 month, response to therapy is assessed as per KDIGO guidelines. In addition to treatment responses screening of urinary tract infections, blood glucose levels, number of lupus flares during treatment will be assessed. Similarly patient will be evaluated every 3 months after the initial maintenance phase till 1 year.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All newly diagnosed Lupus Nephritis with biopsy proven(Classes.
  • III, IV, V, III +V, IV+V) are eligible if they are above 18 year of age.

排除标准

  • 1.Patient having pulmonary alveolar haemorrhage 2.Patient with neuropsychiatric SLE 3.Patient with rapidly progressive renal failure 4.Patient who are on hemodialysis 5.Patient with eGFR less than 25ml per min per 1.73m2 6.Patient with baseline creatinine more than 3mg per dl 7.Patient unwilling to give consent.

结局指标

主要结局

Treatment Response as per KDIGO guidelines, Serum Creatinine , 24hr urine protein

时间窗: 6 months

次要结局

  • Frequency of urinary tract infection in both Arms,Number of Lupus flare in both Arm,(Number of SLE related complications & deaths in each Arms.)

研究者

发起方
DR MANISH RATHI
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR YOGESH E KHANDAGALE

PGIMER

研究点 (1)

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