Chronic Kidney InsufficiencyFLIPNCT00565396
Effectiveness Study on Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3
A study testing Fosinopril and Losartan in people with Chronic Kidney Insufficiency and Angiotensin-Converting Enzyme Inhibitors, run by Shanghai Municipal Health Bureau at 26 sites in China.
Trial summary
The purpose of this study is to determine whether fosinopril and losartan are effective in the treatment of patients with Chronic Kidney Disease(CKD) stage 3. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Insufficiency, Angiotensin-Converting Enzyme Inhibitors, Angiotensin II Type 1 Receptor Blockers
- What is being tested?
- Fosinopril and Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 26 sitesChina
- Study dates
- Sep 2004to Jul 2008
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years old
- Roll out secondary renal diseases
- Do not use steroids and immunosuppresive drugs
- ACEI/ARB treated patients should have 7-14 days wash out period，SiDBP< 110mmHg
- Willing and able to comprehend and give written informed consent
- Willing to follow-up regularly
Who cannot join
- Use steroids and immunosuppresive drugs
- Secondary renal diseases
- Acute cardio-cerebral diseases within 6 months
- Post renal transplantation
- Pregnant/Nursing women
- History of hypersensitivity to ACEI/ARB
- Refuse to join clinical trial
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
The 1st Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Guangxing Hospital
Hangzhou, Zhejiang, 310007
Shaoyifu Hospital
Hangzhou, Zhejiang, 310016
Ningbo Lihuili Hospital
Ningbo, Zhejiang, 315000
Renji Hospital
Shanghai, 200001
Changzheng Hospital
Shanghai, 200003
Shanghai 9th People's Hospital
Shanghai, 200011
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, 200025
Zhongshan Hospital
Shanghai, 200032
Huadong Hospital
Shanghai, 200040
Huashan
Shanghai, 200040
Shanghai 455 Hospital
Shanghai, 200052
Shanghai 85 Hospital
Shanghai, 200052
Tongji Hospital
Shanghai, 200065
Shanghai 10th People's Hospital
Shanghai, 200072
Shanghai 1st People's Hospital
Shanghai, 200080
Shanghai Yangpu District Centre Hospital
Shanghai, 200090
Xinhua Hospital
Shanghai, 200092
Shanghai East Hospital
Shanghai, 200120
Shanghai 6th people's hospital
Shanghai, 200233
Shanghai Changning District Centre Hospital
Shanghai, 200336
Changhai Hospital
Shanghai, 200433
Taizhou People's Hospital
Taizhou, Jiangsu, 225300
Wenling 1st People's Hospital
Wenling, Zhejiang, 317500
The First affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000
Xiangshan People's Hospital
Xiangshan, Zhejiang, 315700
About this study
Official title: Multi-Center,Double-Blind,Randomized,Controlled Clinical Trial of Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3
The purpose of this study is to determine whether fosinopril and losartan are effective in the treatment of patients with Chronic Kidney Disease(CKD) stage 3.
- Conditions
- Chronic Kidney Insufficiency, Angiotensin-Converting Enzyme Inhibitors, Angiotensin II Type 1 Receptor Blockers, Proteinuria
- Being tested
- Fosinopril and Losartan
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosinopril and LosartanDrug
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Fosinopril 10mg/day(oral) Receives: Drug: Fosinopril and Losartan |
| 2 | Active comparator | Fosinopril 20mg/day(oral) Receives: Drug: Fosinopril and Losartan |
| 3 | Active comparator | Losartan 50mg/day(oral) Receives: Drug: Fosinopril and Losartan |
| 4 | Active comparator | Losartan 100mg/day(oral) Receives: Drug: Fosinopril and Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
progress to End Stage Renal Disease
Measured: within two years
double of serum creatinine
Measured: within two years
all cause mortality
Measured: within two years
Secondary outcomes (1)
decreased proteinuria
Measured: within two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startSep 2004
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney InsufficiencyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Municipal Health Bureau
- Sponsor type
- Other government
- Investigators
- Nan Chen, M.D., Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565396
- Sponsor's protocol ID
- 2003ZD002
- Other IDs
- 2003ZD002
- Acronym
- FLIP
- Status last verified
- Nov 2007
- First submitted
- 28 Nov 2007
- Last updated
- 30 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center,Double-Blind,Randomized,Controlled Clinical Trial of Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3
- ClinicalTrials.gov ID
- NCT00565396
- Acronym / sponsor ID
- FLIP / 2003ZD002
- Conditions
- Chronic Kidney Insufficiency, Angiotensin-Converting Enzyme Inhibitors, Angiotensin II Type 1 Receptor Blockers, Proteinuria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Municipal Health BureauOther government
- Study start
- Sep 2004
- Study completion
- Jul 2008 (estimated)
- First posted
- 30 Nov 2007 (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.
The purpose of this study is to determine whether fosinopril and losartan are effective in the treatment of patients with Chronic Kidney Disease(CKD) stage 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Fosinopril and LosartanFosinopril 10mg/day(oral) |
| 2 | Active comparator | Drug: Fosinopril and LosartanFosinopril 20mg/day(oral) |
| 3 | Active comparator | Drug: Fosinopril and LosartanLosartan 50mg/day(oral) |
| 4 | Active comparator | Drug: Fosinopril and LosartanLosartan 100mg/day(oral) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18-75 years old
- Roll out secondary renal diseases
- Do not use steroids and immunosuppresive drugs
- ACEI/ARB treated patients should have 7-14 days wash out period，SiDBP< 110mmHg
- Willing and able to comprehend and give written informed consent
Key exclusion criteria (7 listed)
- Use steroids and immunosuppresive drugs
- Secondary renal diseases
- Acute cardio-cerebral diseases within 6 months
- Post renal transplantation
- Pregnant/Nursing women
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 |
|---|---|---|
| Fosinopril and LosartanFosinopril 10mg/day(oral) Losartan 50mg/day(oral) | Drug | 1, 2, 3, 4 |
Primary outcome
progress to End Stage Renal Disease
Time frame: within two years
double of serum creatinine
Time frame: within two years
all cause mortality
Time frame: within two years
1 secondary outcome
decreased proteinuria
Time frame: within two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2007.
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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.
Nan Chen, M.D. study chair
Ruijin Hospital
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fosinopril and Losartan in people with Chronic Kidney Insufficiency and Angiotensin-Converting Enzyme Inhibitors, run by Shanghai Municipal Health Bureau at 26 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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.
Are results available for this study?
Results are not available in the source record.
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?
progress to End Stage Renal Disease (time frame: within two years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2007.