Chronic Kidney DiseasePhase 4NCT02299310
Effect of Valsartan vs Perindopril on HOMA-IR Index in Patients With Chronic Kidney Disease
A Phase 4 study testing Valsartan and Perindopril in people with Chronic Kidney Disease, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The purpose of this study is to compare the effect of valsartan and perindopril on HOMA-IR Index in patients with chronic kidney disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Valsartan and Perindopril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Dec 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic kidney disease
- Serum creatinine:1~3mg/dl
Who cannot join
- Diabetes
- Patients treated with corticosteroids or immunosuppressants
- BMI>30kg/m2
- SP>180mmHg, DP>110mmHg
- Patients with serious medical problems requiring specific medical treatment
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the effect of valsartan and perindopril on HOMA-IR Index in patients with chronic kidney disease.
Read the detailed description
eligiable volunteers are administrated single-dose over the period I and II (crossover) of Valsartan (80mg) as of Perindopril (4mg).
Every time before and after each medication, HOMA-IR index and other parameters and safety of Valsartan (80mg) and Perindopril (4mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.
- Conditions
- Chronic Kidney Disease
- Being tested
- Valsartan, Perindopril
- Keywords
- Chronic kidney disease, Anti-hypertensive drugs
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
Also called NOVARTIS
Valsartan 80mg/tablet, 1 tablet once daily (crossover)
PerindoprilDrug
Also called ACERTIL
Perindopril 4mg/tablet, 1 tablet once daily (crossover)
| Study group | Role | What they receive |
|---|---|---|
| Valsartan | Experimental | Valsartan 80mg/tablet, 1 tablet once daily (crossover) Receives: Drug: Valsartan |
| Perindopril | Active comparator | Perindopril 4mg/tablet, 1 tablet once daily (crossover) Receives: Drug: Perindopril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homeostasis model of assessment for insulin resistence index (HOMA-IR index)
HOMA-IR=FINS*FGLU/22.5
Measured: 4 weeks
Secondary outcomes (5)
Glomerular filtration rate(eGFR) and Creatinine clearance rate(CCR)
eGFR and CCR are calculated with MDRD formula
Measured: 4 weeks
Body mass index(BMI)
BMI=weight/(height)^2
Measured: 4 weeks
24-h urine protein, urinary albumin-creatinin ration, retinol binding protein
Measured: 4 weeks
Cholesterol, triglycerides, high density lipoprotein, low density lipoprotein
Measured: 4 weeks
Glycosylated hemoglobin
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ri-Bao Wei, Chinese PLA General Hospital
- Investigators
- RiBao Wei, Master, Study chair, Department of Nephrology, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299310
- Sponsor's protocol ID
- S2014-088
- Status last verified
- Nov 2014
- First submitted
- 20 Nov 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Satirapoj B, Leelasiri K, Supasyndh O, Choovichian P. Short-term administration of an angiotensin II receptor blocker in patients with long-term hemodialysis patients improves insulin resistance. J Med Assoc Thai. 2014 Jun;97(6):574-81.
PubMed 25137874Ushijima K, Takuma M, Ando H, Ishikawa-Kobayashi E, Nozawa M, Maekawa T, Shiga T, Fujimura A. Effects of telmisartan and valsartan on insulin sensitivity in obese diabetic mice. Eur J Pharmacol. 2013 Jan 5;698(1-3):505-10. doi: 10.1016/j.ejphar.2012.11.022. Epub 2012 Nov 27.
PubMed 23195328Iwashita M, Sakoda H, Kushiyama A, Fujishiro M, Ohno H, Nakatsu Y, Fukushima T, Kumamoto S, Tsuchiya Y, Kikuchi T, Kurihara H, Akazawa H, Komuro I, Kamata H, Nishimura F, Asano T. Valsartan, independently of AT1 receptor or PPARgamma, suppresses LPS-induced macrophage activation and improves insulin resistance in cocultured adipocytes. Am J Physiol Endocrinol Metab. 2012 Feb 1;302(3):E286-96. doi: 10.1152/ajpendo.00324.2011. Epub 2011 Nov 1.
PubMed 22045314
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Valsartan vs Perindopril on HOMA-IR Index in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02299310
- Acronym / sponsor ID
- S2014-088
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease, Anti-hypertensive drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Nov 2014 (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 compare the effect of valsartan and perindopril on HOMA-IR Index in patients with chronic kidney disease.
Detailed description
eligiable volunteers are administrated single-dose over the period I and II (crossover) of Valsartan (80mg) as of Perindopril (4mg).
Every time before and after each medication, HOMA-IR index and other parameters and safety of Valsartan (80mg) and Perindopril (4mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valsartan | Experimental | Drug: ValsartanValsartan 80mg/tablet, 1 tablet once daily (crossover) |
| Perindopril | Active comparator | Drug: PerindoprilPerindopril 4mg/tablet, 1 tablet once daily (crossover) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of chronic kidney disease
- Serum creatinine:1~3mg/dl
Key exclusion criteria (5 listed)
- Diabetes
- Patients treated with corticosteroids or immunosuppressants
- BMI>30kg/m2
- SP>180mmHg, DP>110mmHg
- Patients with serious medical problems requiring specific medical treatment
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 |
|---|---|---|
| ValsartanAlso: NOVARTISValsartan 80mg/tablet, 1 tablet once daily (crossover) | Drug | Valsartan |
| PerindoprilAlso: ACERTILPerindopril 4mg/tablet, 1 tablet once daily (crossover) | Drug | Perindopril |
Primary outcome
Homeostasis model of assessment for insulin resistence index (HOMA-IR index)
Time frame: 4 weeks
HOMA-IR=FINS*FGLU/22.5
5 secondary outcomes
Glomerular filtration rate(eGFR) and Creatinine clearance rate(CCR)
Time frame: 4 weeks
Body mass index(BMI)
Time frame: 4 weeks
24-h urine protein, urinary albumin-creatinin ration, retinol binding protein
Time frame: 4 weeks
Cholesterol, triglycerides, high density lipoprotein, low density lipoprotein
Time frame: 4 weeks
Glycosylated hemoglobin
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Background: PubMed 25137874Satirapoj B, Leelasiri K, Supasyndh O, Choovichian P. Short-term administration of an angiotensin II receptor blocker in patients with long-term hemodialysis patients improves insulin resistance. J Med Assoc Thai. 2014 Jun;97(6):574-81.
- Background: PubMed 23195328Ushijima K, Takuma M, Ando H, Ishikawa-Kobayashi E, Nozawa M, Maekawa T, Shiga T, Fujimura A. Effects of telmisartan and valsartan on insulin sensitivity in obese diabetic mice. Eur J Pharmacol. 2013 Jan 5;698(1-3):505-10. doi: 10.1016/j.ejphar.2012.11.022. Epub 2012 Nov 27.
- Background: PubMed 22045314Iwashita M, Sakoda H, Kushiyama A, Fujishiro M, Ohno H, Nakatsu Y, Fukushima T, Kumamoto S, Tsuchiya Y, Kikuchi T, Kurihara H, Akazawa H, Komuro I, Kamata H, Nishimura F, Asano T. Valsartan, independently of AT1 receptor or PPARgamma, suppresses LPS-induced macrophage activation and improves insulin resistance in cocultured adipocytes. Am J Physiol Endocrinol Metab. 2012 Feb 1;302(3):E286-96. doi: 10.1152/ajpendo.00324.2011. Epub 2011 Nov 1.
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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.
RiBao Wei, Master study chair
Department of Nephrology, Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valsartan and Perindopril in people with Chronic Kidney Disease, run by Chinese PLA General Hospital at 1 site 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 2 inclusion and 5 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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RiBao Wei, Master (+861055499133, wrbbj2006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostasis model of assessment for insulin resistence index (HOMA-IR index) (time frame: 4 weeks). 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 NCT02299310, which also lists 3 linked publications.
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 2 Dec 2014.