CSPPT- Chronic Kidney Diseases Study

NCT01871740 | Withdrawn Phase 4 DMC

• 1 other identifier: Ausa-CSPPT-CKD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension; Hyperhomocysteinemia

Keywords

Folic acid; Renal function decline; Hypertension; Hyperhomocysteinemia; Chronic kidney disease; MTHFR C677T genotype; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• 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.

• New-onset albuminuria

  Albuminuria was examined at baseline and at the final visit (5 years) of the trial.

• A composite of renal events.

  Every 3 months during the trial, up to 5 years

Study Arms (2)

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.

Drug: Enalapril maleate and folic acid tablets

Enalapril maleate

ACTIVE COMPARATOR

Enalapril maleate 10 mg per day is given

Drug: Enalapril maleate

Interventions

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.

Enalapril maleate and folic acid tablets

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.

Also known as: Lameiya(Yabao Pharmaceutical)

Enalapril maleate

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BP≥140/90 mmHg in both of the two screening visits or currently under anti-hypertension treatment;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Ausa Pharmed Co.,Ltd: lead
• Nanfang Hospital, Southern Medical University: collaborator

Study Sites (2)

Anqing Branch, Anhui Institute of Biomedical Research

Anqing, Anhui, 246000, China

Location

Lianyungang Center for Advanced Research in Cardiovascular Diseases

Lianyungang, Jiangsu, 222003, China

Location

MeSH Terms

Conditions

Hypertension; Hyperhomocysteinemia; Renal Insufficiency, Chronic

Interventions

Enalapril; Folic Acid

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Fanfan Hou, MD

  Division of Nephrology, Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

• Xin Xu, MD

  Guangdong Provincial Institute of Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 7, 2013
• Study Start: May 1, 2008
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

CN (2)