CSPPT- Chronic Kidney Diseases Study (CSPPT-CKD)

Shenzhen Ausa Pharmed

Status and phase: Withdrawn; Phase 4

Conditions: Hypertension; Hyperhomocysteinemia

Treatments: Drug: Enalapril maleate; Drug: Enalapril maleate and folic acid tablets

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01871740

Ausa-CSPPT-CKD

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BP≥140/90 mmHg in both of the two screening visits or currently under anti-hypertension treatment;
• 45-75 years old;
• Successful determination of methylenetetrahydrofolate reductase (MTHFR) C677T genotype;
• For pre-menopausal women, agreed to use contraceptives during the trial;
• Signed the written informed consent.

Exclusion criteria

• Having a history of stroke;
• Having a history of myocardial infarction;
• Having a history of physician diagnosed heart failure;
• Post- coronary revascularization;
• Severe somatic disease such as cancer;
• Secondary hypertension;
• Congenital or acquired organic heart diseases;
• Contraindicated to angiotensin-converting enzyme inhibitor (ACEI);
• Having a history of ACEI adverse effects;
• Currently long-term use of folic acid or vitamin B12 or vitamin B6;
• Pregnant or child breastfeeding women;
• Severe mental disorders;
• Lab tests indicating abnormal liver or kidney function;
• Unwilling to participate the trial;
• Unwilling to change the current antihypertensive treatment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Enalapril maleate and folic acid tablets

Experimental group

Description:

A fixed combination drug is given. The dose is fixed in enalapril 10 mg / folic acid 0.8 mg per day.

Treatment:

Drug: Enalapril maleate and folic acid tablets

Enalapril maleate

Active Comparator group

Description:

Enalapril maleate 10 mg per day is given

Treatment:

Drug: Enalapril maleate