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The sponsor and the PIs both agreed that the CSPPT-CKD should be a sub-study of the CSPPT insted of an independent randomized trial.
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| Name | Class |
|---|---|
| Nanfang Hospital, Southern Medical University | OTHER |
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The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more effective in preventing renal function decline among the patients with primary hypertension when compared to enalapril maleate.
Elevated blood concentration of homocysteine (Hcy) has been suggested as a modifiable, independent risk factor for coronary artery disease, stroke, and deep vein thrombosis. Prevalence of hyperhomocysteinemia and folic acid deficiency in China are significantly higher than those in Europe and USA. The investigators' preliminary research demonstrated that blood concentration of Hcy was negatively correlated to estimated glomerular filtration rate (eGFR), a key index of kidney function. However, the question as to whether Hcy-lowering therapy with folic acid can reduce the risk of chronic kidney disease(CKD) remains to be answered.
This study, exploiting the hypertensive population of CSPPT trial (ClinicalTrials.gov register number: NCT00794885), is intended to compare the effects of enalapril maleate and folic acid tablets versus enalapril maleate in preventing renal function decline among the patients with primary hypertension. The results from this trial may have the potential to transform current clinical and public health findings into practice in the prevention of chronic kidney disease(CKD) in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enalapril maleate and folic acid tablets | Experimental | A fixed combination drug is given. The dose is fixed in enalapril 10 mg / folic acid 0.8 mg per day. |
|
| Enalapril maleate | Active Comparator | Enalapril maleate 10 mg per day is given |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enalapril maleate and folic acid tablets | Drug | Enalapril maleate and folic acid tablets, (10mg/0.8mg)/tablet, taken orally and once daily for a maximum of 5 years. Combination with other anti-hypertension drugs are allowed. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fanfan Hou, MD | Division of Nephrology, Nanfang Hospital, Southern Medical University | Principal Investigator |
| Xin Xu, MD | Guangdong Provincial Institute of Nephrology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anqing Branch, Anhui Institute of Biomedical Research | Anqing | Anhui | 246000 | China | ||
| Lianyungang Center for Advanced Research in Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D020138 | Hyperhomocysteinemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
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| ID | Term |
|---|---|
| D004656 | Enalapril |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Enalapril maleate | Drug | Enalapril, 10mg/tablet, taken orally once daily for a maximum of 5 consecutive years. Combination with other anti-hypertension drugs are allowed. |
|
|
| 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 |
| Lianyungang |
| Jiangsu |
| 222003 |
| China |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008286 | Malabsorption Syndromes |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011622 |
| Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |