Early Screening and Diagnosis of CKD

NCT ID: NCT02841371

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-01
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Kidney; Disease (Functional); Chronic Kidney Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

chronic kidney disease (CKD)

chronic kidney disease (CKD) is defined as abnormalities of kidney structure (markers of kidney damage) or function (decreased GFR by 99mTc-DTPA renal clearance and/or eGFR), present for more than 3 months.

99mTc-DTPA

Intervention Type: RADIATION

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

no CKD

Suspected chronic kidney disease but no chronic kidney disease after screening by abnormalities of kidney structure (markers of kidney damage) or function (decreased GFR by 99mTc-DTPA renal clearance and/or eGFR), present for less than 3 months, or no abnormalities of kidney structure or function.

99mTc-DTPA

Intervention Type: RADIATION

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

Interventions

99mTc-DTPA

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

Intervention Type: RADIATION

Other Intervention Names

technetium-99m-labeled diethylenetriaminepentaacetic acid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xin Du

Role: PRINCIPAL_INVESTIGATOR

Nanjing First Hospital, Nanjing Medical University

Locations

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xin Du, MD

Role: CONTACT

duxin168@163.com

86-025-87726209

Facility Contacts

Xin Du, MD

Role: primary

Other Identifiers

ES-CKD

Identifier Type: -

Identifier Source: org_study_id