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Effect of RAAS Blockade on Renal Outcome in CKD Stage 3-4 with Type 2 DM Patients: A Retrospective cohort study

Conditions
chronic kidney disease stage 3-4 type 2 diabetes mellitus
chronic kidney disease
diabetes mellitus
Registration Number
TCTR20230512002
Lead Sponsor
Faculty of Pharmaceutical Sciences, Burapha University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
nknown
Sex
All
Target Recruitment
13488
Inclusion Criteria

1) was Thai people
2) aged 15 years or older at the time of first diagnosis of CKD stage 3to4
3) were diagnosed CKD stage 3to4 with ICD10 TM codes N18.3to18.4 and had eGFR <60 mL/min/1.73 m2 on two or more times between October 1, 2018 to September 30, 2019 with calculated eGFR from the CKD-EPI equation
4) had the frequent hospital visits and at least one patient record after being diagnosed and confirmed as CKD stage 3to4 between 1 October 2018 to 30 September 2022 ( Three year observation)
5) had the hospital service records either in the outpatient or inpatient department services of 120 middle level community hospitals (M1 and M2) in Thailand
6) had the records of demographic data and the data fpr Propensity score matching between Users and Non-users; age, sex, body mass index (BMI), first date of diagnosed CKD stage 3to4 (index date), glycemic control value (HbA1C), and eGFR at baseline, systolic blood pressure (SBP) and Charlson comorbidity index (CCI)
7) had the records of clinical laboratory data; HbA1C, Proteinuria, fasting plasma glucose, serum creatinine and serum potassium

Exclusion Criteria

1)received the dual groups of Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) or switching between both groups during the observation period
2)had systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher 90 mmHg or HbA1C higher than 7% or heavy proteinuria with proteinuria greater than or equal to 3.5 g/day or a spot urine protein creatinine ratio (UPCR) > 3.5 g/g
3)was diagnosed with cancer in any body parts with ICD 10 TM codes C00toC99, D00toD48, or other conditions that may lead to rapid deterioration of the kidneys include shock with ICD 10 R57 and sepsis infection in blood with ICD 10 A40toA41
4)were pregnant between 1 October 2018 to 30 September 2022 with ICD 10 TM codes Z33
5)died during the observation period by using data from DEATH file and with ICD 10 TM codes Z33R95toR99
6)had missing data or lack of matching data between users and non users

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Renal outcome in 1095 day observation (3 years) since study entry date eGFR change
Secondary Outcome Measures
NameTimeMethod
Incidence of ESRD in 1095 day observation (3 years) since study entry date ICD 10 TM
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