CSPPT- Chronic Kidney Diseases Study

NCT ID: NCT01871740

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2014-08-31

Brief Summary

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.

Detailed 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.

Conditions

Hypertension; Hyperhomocysteinemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Enalapril maleate and folic acid tablets

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

Group Type: EXPERIMENTAL

Enalapril maleate and folic acid tablets

Intervention Type: 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.

Enalapril maleate

Enalapril maleate 10 mg per day is given

Group Type: ACTIVE_COMPARATOR

Enalapril maleate

Intervention Type: DRUG

Enalapril, 10mg/tablet, taken orally once daily for a maximum of 5 consecutive years. Combination with other anti-hypertension drugs are allowed.

Interventions

Enalapril maleate and folic acid tablets

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.

Intervention Type: DRUG

Enalapril maleate

Enalapril, 10mg/tablet, taken orally once daily for a maximum of 5 consecutive years. Combination with other anti-hypertension drugs are allowed.

Intervention Type: DRUG

Other Intervention Names

Lameiya(Yabao Pharmaceutical)

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

Shenzhen Ausa Pharmed Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fanfan Hou, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, Nanfang Hospital, Southern Medical University

Xin Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial Institute of Nephrology

Locations

Anqing Branch, Anhui Institute of Biomedical Research

Anqing, Anhui, China

Lianyungang Center for Advanced Research in Cardiovascular Diseases

Lianyungang, Jiangsu, China

Countries

China

Other Identifiers

Ausa-CSPPT-CKD

Identifier Type: -

Identifier Source: org_study_id