Clinical trial NCT01871740: CSPPT- Chronic Kidney Diseases Study
Official title: Enalapril Maleate and Folic Acid Tablets for Prevention of Chronic Kidney Diseases in Patients With Hypertension: a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hypertension
Hyperhomocysteinemia
Keywords: Folic acid
Renal function decline
Hypertension
Hyperhomocysteinemia
Chronic kidney disease
MTHFR C677T genotype
Randomized controlled trial
Lead sponsor: Shenzhen Ausa Pharmed Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Nanfang Hospital, Southern Medical University
First posted: 2013-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Renal function decline
timeFrame: Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.
Secondary outcomes:
measure: Average decline rate in eGFR (ml/min/1.73m2/yr).
timeFrame: Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.
measure: New-onset chronic kidney disease based on eGFR（eGFR<60 ml/min/1.73 m2）
timeFrame: Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.
measure: New-onset albuminuria
timeFrame: Albuminuria was examined at baseline and at the final visit (5 years) of the trial.
measure: A composite of renal events.
timeFrame: Every 3 months during the trial, up to 5 years
Other outcomes:
Locations:
city: Anqing
country: China
facility: Anqing Branch, Anhui Institute of Biomedical Research
state: Anhui
city: Lianyungang
country: China
facility: Lianyungang Center for Advanced Research in Cardiovascular Diseases
state: Jiangsu
Study officials:
affiliation: Division of Nephrology, Nanfang Hospital, Southern Medical University
name: Fanfan Hou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Provincial Institute of Nephrology
name: Xin Xu, MD
role: PRINCIPAL_INVESTIGATOR
References: