| Trial ID: | L0127 |
| Source ID: | NCT01871740
|
| Associated Drug: |
Enalapril Maleate And Folic Acid Tablets
|
| Title: |
CSPPT- Chronic Kidney Diseases Study
|
| Acronym: |
CSPPT-CKD
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypertension|Hyperhomocysteinemia
|
| Interventions: |
DRUG: Enalapril maleate and folic acid tablets|DRUG: Enalapril maleate
|
| Outcome Measures: |
Primary: Renal function decline, Renal function decline was defined based on one of more of the following : (1) A certain drop in eGFR, was defined as a drop in GFR category (≥90\[G1\], 60-89\[G2\], 45-59\[G3a\], 30-44\[G3b\], 15-29\[G4\], \<15\[G5\] ml/min/1.73m2) accompanied by a 25% or greater drop in eGFR from baseline; (2) Rapid progression, was defined as a sustained decline in eGFR of more than 5 ml/min/1.73m2/yr., Serum creatinine was examined at baseline and at the final visit (5 years) of the trial. | Secondary: Average decline rate in eGFR (ml/min/1.73m2/yr)., Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.|New-onset chronic kidney disease based on eGFR（eGFR<60 ml/min/1.73 m2）, Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.|New-onset albuminuria, Albuminuria was examined at baseline and at the final visit (5 years) of the trial.|A composite of renal events., The composite endpoint is consisted of: 1)End stage renal disease (ESRD);2)Doubling of serum creatinine; and 3)Renal disease-induced death., Every 3 months during the trial, up to 5 years
|
| Sponsor/Collaborators: |
Sponsor: Shenzhen Ausa Pharmed Co.,Ltd | Collaborators: Nanfang Hospital, Southern Medical University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2008-05
|
| Completion Date: |
2014-08
|
| Results First Posted: |
|
| Last Update Posted: |
2016-01-20
|
| Locations: |
Anqing Branch, Anhui Institute of Biomedical Research, Anqing, Anhui, 246000, China|Lianyungang Center for Advanced Research in Cardiovascular Diseases, Lianyungang, Jiangsu, 222003, China
|
| URL: |
https://clinicaltrials.gov/show/NCT01871740
|
