Early Screening and Diagnosis of CKD

NCT02841371 | Unknown DMC

• 1 other identifier: ES-CKD
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney; Disease (Functional); Chronic Kidney Disease

Keywords

estimated glomerular filtration rate; serum creatinine; serum cystatin C; chronic kidney disease

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Accuracy of estimated GFR more than 70%

  Accuracy was calculated as the proportion of estimated GFR within 30% of reference GFR.

  1 year

Secondary Outcomes (2)

• net reclassification index more than 10%

  1 year

• 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

  1 year

Study Arms (2)

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.

Radiation: 99mTc-DTPA

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.

Radiation: 99mTc-DTPA

Interventions

99mTc-DTPA RADIATION

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

Also known as: technetium-99m-labeled diethylenetriaminepentaacetic acid

chronic kidney disease (CKD); no CKD

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese participants with CKD were selected from Nanjing First Hospital in China. All patients met the diagnostic criteria of CKD according to National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (K/DOQI) clinical practice guidelines.

You may qualify if:

• Health examination population at the department of nephrology
• Chronic kidney disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Disease; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Study Officials

• Xin Du

  Nanjing First Hospital, Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Du, MD

CONTACT

86-025-87726209; duxin168@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 22, 2016
• Study Start: August 1, 2009
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

CN (1)