CTRI/2020/02/023109尚未招募1 期
A prospective, open label, two arm, phase I clinical study to evaluate the safety and efficacy of R-HSC-010 in patients with chronic kidney disease
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Must be able to give voluntary written informed consent
- •2. Age 18 to 65 years
- •3. BMI between 18-30 kg/m2
- •4. Patients with stage III chronic kidney disease
- •5. Subjects with moderate to severe albuminuria ââ?°Â¥30 mg/g (ââ?°Â¥3 mg/mmol)
- •6. Proteinuria >1 gm/day
- •7. Subjects should have LVEF > 45% as confirmed by 2D ââ?¬â??ECHO
- •8. Patient should be afebrile 24 hours prior to procedure
- •9. Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin <2 times upper limit of normal (ULN)
- •10. Females of childbearing potential must have negative serum pregnancy test at screening and agree to use adequate contraception throughout the study period
排除标准
- •1. Patients with Acute Renal Failure
- •2. Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores or any other condition which will contraindicate the use of study treatment or procedures
- •3. Chronic kidney disease due to autoimmune etiology, connective tissue disease, amyloidosis and storage disorders
- •4. Haemoglobin less than 9 gm/dl
- •5. Uncontrolled Diabetes mellitus with HbA1C ââ?°Â¥ 8.0%
- •6. Patients with HIV, HBsAg and HCV test positive
- •7. Known bleeding or coagulation disorder
- •8. Known hematologic disease
- •9. Evidence of active malignancy within one year prior to IP administration
- •10. Severe skin infection or osteomyelitis
- •11. Pregnant or breast feeding, or planning to become pregnant during study period
- •12. Patients on immunosuppressive therapy
- •13. History of drug or alcohol abuse
- •14. Presence of ongoing local or systemic infection
- •15. Subjects judged by the investigator to be at significant risk of failing to comply with the requirements of the protocol
- •16. Treatment with an investigational product within 1 year prior to trial entry
- •17. Uncontrolled hypertension (systolic blood pressure >140 mmHg and diastolic blood pressure > 90 mmHg)
- •18. Participation in any other clinical trial over the past 1 year.
研究者
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