HypertensionPhase 4CSPPT-CKDNCT01871740

CSPPT- Chronic Kidney Diseases Study

A Phase 4 study testing Enalapril maleate and folic acid tablets and Enalapril maleate in people with Hypertension and Hyperhomocysteinemia, run by Shenzhen Ausa Pharmed Co.,Ltd at 2 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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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. Read more about this study

Who is it for?: Ages 45 to 75 years
Conditions the study is for: Hypertension, Hyperhomocysteinemia
What is being tested?: Enalapril maleate and folic acid tablets and Enalapril maleate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 2 sitesChina
Study dates: May 2008to Aug 2014
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Anqing Branch, Anhui Institute of Biomedical Research
Anqing, Anhui, 246000
Lianyungang Center for Advanced Research in Cardiovascular Diseases
Lianyungang, Jiangsu, 222003

Other trials in China

About this 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

Read the 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
Being tested: Enalapril maleate and folic acid tablets, Enalapril maleate
Keywords: Folic acid, Renal function decline, Hypertension, Hyperhomocysteinemia, Chronic kidney disease, MTHFR C677T genotype, Randomized controlled trial
Medical subject headings: Hypertension, Hyperhomocysteinemia, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enalapril maleate and folic acid tabletsDrug
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 maleateDrug
Also called Lameiya(Yabao Pharmaceutical)
Enalapril, 10mg/tablet, taken orally once daily for a maximum of 5 consecutive years. Combination with other anti-hypertension drugs are allowed.

Study groups in NCT01871740
Study group	Role	What they receive
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. Receives: Drug: Enalapril maleate and folic acid tablets
Enalapril maleate	Active comparator	Enalapril maleate 10 mg per day is given Receives: Drug: Enalapril maleate

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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）
Measured: Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.
New-onset albuminuria
Measured: Albuminuria was examined at baseline and at the final visit (5 years) of the trial.
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.
Measured: Every 3 months during the trial, up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Aug 2014

First posted7 Jun 2013 (estimated)
Study startMay 2008
Primary completionJun 2014
Study completionAug 2014 (estimated)

Why it 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01871740
Sponsor's protocol ID: Ausa-CSPPT-CKD
Acronym: CSPPT-CKD
Status last verified: Jan 2016
First submitted: 29 May 2013
Last updated: 20 Jan 2016
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enalapril Maleate and Folic Acid Tablets for Prevention of Chronic Kidney Diseases in Patients With Hypertension: a Double-blind Randomized Controlled Trial
ClinicalTrials.gov ID: NCT01871740
Acronym / sponsor ID: CSPPT-CKD / Ausa-CSPPT-CKD
Conditions: Hypertension, Hyperhomocysteinemia
Keywords: Folic acid, Renal function decline, Hypertension, Hyperhomocysteinemia, Chronic kidney disease, MTHFR C677T genotype, Randomized controlled trial
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason 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.
Enrolment: 0 participants (actual)
Lead sponsor: Shenzhen Ausa Pharmed Co.,LtdIndustry (pharma, biotech, devices)
Collaborators: Nanfang Hospital, Southern Medical University
Study start: May 2008
Primary completion: Jun 2014 (actual)
Study completion: Aug 2014 (estimated)
First posted: 7 Jun 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Enalapril maleate and folic acid tablets	Experimental	Drug: Enalapril maleate and folic acid tabletsA fixed combination drug is given. The dose is fixed in enalapril 10 mg / folic acid 0.8 mg per day.
Enalapril maleate	Active comparator	Drug: Enalapril maleateEnalapril maleate 10 mg per day is given

Who may qualify

Ages: 45 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enalapril maleate and folic acid tabletsEnalapril 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.	Drug	Enalapril maleate and folic acid tablets
Enalapril maleateAlso: Lameiya(Yabao Pharmaceutical)Enalapril, 10mg/tablet, taken orally once daily for a maximum of 5 consecutive years. Combination with other anti-hypertension drugs are allowed.	Drug	Enalapril maleate

Primary outcome

Renal function decline
Time frame: Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.
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.

4 secondary outcomes

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.
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.
New-onset albuminuria
Time frame: Albuminuria was examined at baseline and at the final visit (5 years) of the trial.
A composite of renal events.
Time frame: Every 3 months during the trial, up to 5 years

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fanfan Hou, MD principal investigator

Division of Nephrology, Nanfang Hospital, Southern Medical University

Xin Xu, MD principal investigator

Guangdong Provincial Institute of Nephrology

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Enalapril maleate and folic acid tablets and Enalapril maleate in people with Hypertension and Hyperhomocysteinemia, run by Shenzhen Ausa Pharmed Co.,Ltd at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Renal function decline (time frame: Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01871740.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.