Early Screening and Diagnosis of CKD

Chronic Kidney Disease Clinical Trial

Official title:

Early Screening and Diagnosis of Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02841371
• Other study ID #: ES-CKD
• Status: Recruiting
• Start date: August 1, 2009
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Xin Du, MD
• Phone: 86-025-87726209
• Email: duxin168[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic kidney disease (CKD) is a global public health problem. The prevalence of CKD in adults in China was 10.8%. Albuminuria measurement and estimating glomerular filtration rate (GFR) are the primary means of screening for CKD in epidemiological investigations. However, there are many important problems to be solved, whether albuminuria test or GFR evaluation. The investigators aim to detect thrice albumin-creatinine ratio (ACR) within three months, with simultaneous test of urinary protein-creatinine ratio (PCR), 24-hour urine protein excretion rate (PER) and 24-hour albumin albumin excretion rate (AER) to compare the effects of different times of screening for CKD and observe the daily physiological variation of ACR, PCR, AER and PER, derive ACR and PCR reference value on the basis of different genders, in order to facilitate the early diagnosis of CKD. Meanwhile, for more accurate assessment of GFR in Chinese populations, the investigators intend to validate beta-trace protein (BTP) based equation to evaluate GFR compared with 99mTc-diethylenetriamine pentaacetic acid (DTPA) renal clearance method. Then to develop GFR estimation equation based on the combination of serum creatinine, cystatin C, β2 -microglobulin and BTP applicable in China.

Description:

Chronic kidney disease (CKD) is a global public health problem. The prevalence of CKD in adults in China was 10.8%. Awareness of CKD is only 10.04% from a national cross-sectional survey in China. CKD is characterised by decreased estimated glomerular filtration rate (eGFR) and increased albuminuria, present for more than three months, and is associated with adverse outcomes (all-cause mortality, acute kidney injury, and end-stage renal disease), independent of hypertension and diabetes, age, or sex. CKD may carry a coronary heart disease risk similar to that of diabetes. The estimated lifetime risk of CKD stage 3a was more than 50%, lower than that of hypertension (83%-90% for a 55-year-old), but higher than those for diabetes (33%-39%), coronary heart disease (32%-49% for a 40-year-old), and invasive cancer (38%-45%).

Albuminuria measurement and estimating glomerular filtration rate (GFR) are the primary means of screening for CKD in epidemiological investigations. However, there are many important problems to be solved, whether albuminuria test or GFR evaluation. The investigators aim to detect thrice albumin-creatinine ratio (ACR) within three months, with simultaneous test of urinary protein-creatinine ratio (PCR), 24-hour urine protein excretion rate (PER) and 24-hour albumin excretion rate (AER) to compare the effects of different times of screening for CKD and observe the daily physiological variation of ACR, PCR, AER and PER, and repeat test to reduce the physiological variation, and further derive ACR and PCR reference value on the basis of different genders, in order to facilitate the early diagnosis of CKD. Meanwhile, for more accurate assessment of GFR in Chinese populations, the investigators intend to validate beta-trace protein (BTP) based equation to evaluate GFR compared with 99mTc-diethylenetriamine pentaacetic acid (DTPA) renal clearance method. Then the investigators aim to develop GFR estimation equation based on the combination of serum creatinine, cystatin C, β2-microglobulin and BTP applicable in China, for early and accurate assessment of GFR in Chinese people, and develop appropriate software to estimating GFR.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Health examination population at the department of nephrology

• Chronic kidney disease

Exclusion Criteria:

• Severe heart failure

• Acute renal failure

• Pleural or abdominal effusion

• Serious edema or malnutrition

• Skeletal muscle atrophy

• Amputation

• Ketoacidosis

• Patients who were taking trimethoprim or cimetidine or angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blocker (ARB)

• Patients who had recently received glucocorticoid and hemodialysis therapy

• Female during the menstrual period

• Pregnant woman

• Who unable to sign informed consent

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Kidney; Disease (Functional)
• Renal Insufficiency, Chronic

Intervention

Radiation:
• 99mTc-DTPA
a 99mTc-DTPA renal dynamic imaging measurement as the reference glomerular filtration rate (rGFR).

Locations

Country	Name	City	State
China	Nanjing First Hospital, Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bias of estimated GFR less than 5 ml per minute per 1.73 m2 versus reference GFR	Bias was defined as the median results of differences between estimated GFR and reference GFR (eGFR- rGFR).	1 year
Primary	Precision of estimated GFR less than 30 ml per minute per 1.73 m2 versus reference GFR	Precision was defined as the interquartile range (IQR) of the differences between estimated GFR and reference GFR.	1 year
Primary	Accuracy of estimated GFR more than 70%	Accuracy was calculated as the proportion of estimated GFR within 30% of reference GFR.	1 year
Secondary	net reclassification index more than 10%	Net reclassification improvement (NRI) was defined as the sum of those classified upward to higher risk in those with an event plus those classified downward to lower risk in those without an event less the sum of those classified downward to lower risk in those with an event plus those classified to higher risk in those without an event. The event in this study was having a measured GFR that was less than 60 ml per minute per 1.73 m2.	1 year
Secondary	Composite outcomes of sensitivity of a single screen using estimated GFR and/or albuminuria to detect CKD more than 0.6, or specificity of a single screen using estimated GFR and/or albuminuria to detect CKD more than 0.8	Sensitivity of a single screen using estimated GFR and/or albuminuria to detect CKD more than 0.6, or specificity of a single screen using estimated GFR and/or albuminuria to detect CKD more than 0.8	1 year