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CSPPT- Chronic Kidney Diseases Study (CSPPT-CKD)

Primary Purpose

Hypertension, Hyperhomocysteinemia

Status
Withdrawn
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Enalapril maleate and folic acid tablets
Enalapril maleate
Sponsored by
Shenzhen Ausa Pharmed Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Folic acid, Renal function decline, Hypertension, Hyperhomocysteinemia, Chronic kidney disease, MTHFR C677T genotype, Randomized controlled trial

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Anqing Branch, Anhui Institute of Biomedical Research
  • Lianyungang Center for Advanced Research in Cardiovascular Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enalapril maleate and folic acid tablets

Enalapril maleate

Arm Description

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

Enalapril maleate 10 mg per day is given

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Average decline rate in eGFR (ml/min/1.73m2/yr).
New-onset chronic kidney disease based on eGFR（eGFR<60 ml/min/1.73 m2）
New-onset albuminuria
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.

Full Information

First Posted
May 29, 2013
Last Updated
January 18, 2016
Sponsor
Shenzhen Ausa Pharmed Co.,Ltd
Collaborators
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01871740
Brief Title
CSPPT- Chronic Kidney Diseases Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Withdrawn
Why Stopped
The sponsor and the PIs both agreed that the CSPPT-CKD should be a sub-study of the CSPPT insted of an independent randomized trial.
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Ausa Pharmed Co.,Ltd
Collaborators
Nanfang Hospital, Southern Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hyperhomocysteinemia
Keywords
Folic acid, Renal function decline, Hypertension, Hyperhomocysteinemia, Chronic kidney disease, MTHFR C677T genotype, Randomized controlled trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enalapril maleate and folic acid tablets
Arm Type
Experimental
Arm Description
A fixed combination drug is given. The dose is fixed in enalapril 10 mg / folic acid 0.8 mg per day.
Arm Title
Enalapril maleate
Arm Type
Active Comparator
Arm Description
Enalapril maleate 10 mg per day is given
Intervention Type
Drug
Intervention Name(s)
Enalapril maleate and folic acid tablets
Intervention Description
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
Intervention Name(s)
Enalapril maleate
Other Intervention Name(s)
Lameiya(Yabao Pharmaceutical)
Intervention Description
Enalapril, 10mg/tablet, taken orally once daily for a maximum of 5 consecutive years. Combination with other anti-hypertension drugs are allowed.
Primary Outcome Measure Information:
Title
Renal function decline
Description
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.
Time Frame
Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.
Secondary Outcome Measure Information:
Title
Average decline rate in eGFR (ml/min/1.73m2/yr).
Time Frame
Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.
Title
New-onset chronic kidney disease based on eGFR（eGFR<60 ml/min/1.73 m2）
Time Frame
Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.
Title
New-onset albuminuria
Time Frame
Albuminuria was examined at baseline and at the final visit (5 years) of the trial.
Title
A composite of renal events.
Description
The composite endpoint is consisted of: 1)End stage renal disease (ESRD);2)Doubling of serum creatinine; and 3)Renal disease-induced death.
Time Frame
Every 3 months during the trial, up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanfan Hou, MD
Organizational Affiliation
Division of Nephrology, Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xin Xu, MD
Organizational Affiliation
Guangdong Provincial Institute of Nephrology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anqing Branch, Anhui Institute of Biomedical Research
City
Anqing
State/Province
Anhui
ZIP/Postal Code
246000
Country
China
Facility Name
Lianyungang Center for Advanced Research in Cardiovascular Diseases
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222003
Country
China

12. IPD Sharing Statement

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CSPPT- Chronic Kidney Diseases Study

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