Renal reserve and its association with renal function at 6 months post living kidney donation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To measure renal functional reserve using iohexol clearance using protein load in prospective living kidney donors before kidney donation
研究概览
简要总结
Serum creatinine and glomerular filtration rate (GFR) are currently used to measure kidney function in clinical practices. The baseline GFR does not reflect full kidney function as kidney does not work at its maximum capacity under normal conditions. GFR increases acutely after heavy protein load and the increase represents recruitment of reserve. This increase is called renal functional reserve (RFR). It has been shown that measured GFR in normal individuals of Indian ethnicity is lower than that in Western population. It is not known whether that is physiological or pathological. Plasma clearance of iohexol is the current gold standard for measurement of GFR. We have already established procedures for measurement of GFR by plasma clearance of iohexol. Assessment of RFR, using most accurate reference method to measure GFR such as plasma disappearance of iohexol, is important to ascertain significance of low normal GFR in Indian population. The proposed study aims to evaluate RFR of healthy Indian subjects after protein load using standard method of measurement of GFR i.e. using plasma iohexol clearance. We propose to measure the RFR in prospective living renal donors who are extensively worked up to assess normality of clinical status. Pre and Post protein loading GFR will be measured by multiple sample plasma clearance of iohexol. Iohexol will be analyzed by HPLC. We aim to analyse association of RFR with post kidney donation renal function at 6 months in living renal donors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Age 18 to 50 years Voluntary kidney donor.
排除标准
- •Subjects with pre-existing comorbidities or history of systemic hypertension, diabetes mellitus, coronary artery disease, chronic obstructive pulmonary disease, renal stone disease or chronic liver disease
- •History of active malignancy or treatment for malignancy in the past
- •Pregnancy, in case of females
- •History of voiding dysfunction
- •Allergy to iohexol or iodinated contrast media
- •Subjects with lactose intolerance or allergy to milk / milk based products.
结局指标
主要结局
To measure renal functional reserve using iohexol clearance using protein load in prospective living kidney donors before kidney donation
时间窗: To measure renal functional reserve in prospective living kidney donors and its association with renal function 6 months post kidney donation
次要结局
- 1) To ascertain association of pre-donation renal functional reserve with measured GFR at 6 months after kidney donation in living kidney donors(2) To ascertain bias between measured GFR & estimated GFR (by CKD-EPICr 2021) at 6 months after kidney donation in living kidney donors)
研究者
Amit Ganwani
PGIMER
