CSPPT- Chronic Kidney Diseases Study

Hypertension Clinical Trial

— CSPPT-CKD  

Official title:

Enalapril Maleate and Folic Acid Tablets for Prevention of Chronic Kidney Diseases in Patients With Hypertension: a Double-blind Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01871740
• Other study ID #: Ausa-CSPPT-CKD
• Status: Withdrawn
• Phase: Phase 4
• First received: May 29, 2013
• Last updated: January 18, 2016
• Start date: May 2008
• Est. completion date: August 2014

Study information

• Verified date: January 2016
• Source: Shenzhen Ausa Pharmed Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperhomocysteinemia
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
China	Anqing Branch, Anhui Institute of Biomedical Research	Anqing	Anhui
China	Lianyungang Center for Advanced Research in Cardiovascular Diseases	Lianyungang	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen Ausa Pharmed Co.,Ltd	Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	No
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.	No
Secondary	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.	No
Secondary	New-onset albuminuria		Albuminuria was examined at baseline and at the final visit (5 years) of the trial.	No
Secondary	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	No