End Stage Renal Failure on DialysisPhase 2NCT00732069

Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis

A Phase 2 study testing Ramipril and Valsartan in people with End Stage Renal Failure on Dialysis and Complication of Hemodialysis, run by Vanderbilt University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: End Stage Renal Failure on Dialysis, Complication of Hemodialysis
What is being tested?: Ramipril and Valsartan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 19 participants
Where: 1 siteUnited States
Study dates: Aug 2008to Dec 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 years or older
On thrice-weekly chronic hemodialysis for at least 6 months
Clinically stable, adequately dialyzed (single-pool Kt/V> 1.2) thrice weekly, with polysulphone membrane for at least 3 consecutive months prior to study

Who cannot join

Body mass index > 35 mg/kg
History of functional transplant less than 6 months prior to study
Use of anti-inflammatory medications other than aspirin < 325 mg/d
History of active connective tissue disease
History of acute infectious disease within one month prior to study
AIDS (HIV seropositivity is not an exclusion criteria)

Show all 19Show fewer

History of myocardial infarction or cerebrovascular event within 3 months
Advanced liver disease
Gastrointestinal dysfunction requiring parental nutrition
Active malignancy excluding basal cell carcinoma of the skin
History of ACE inhibitor-associated cough or angioedema
Ejection fraction less than 40%
Inability to discontinue ACE inhibitor or ARB
Predialysis potassium repeatedly higher than 5.5 mmol/L (confirmed on a repeated blood draw)
Anticipated live donor kidney transplant
Use of vitamin E >60 IU/d or vitamin C >500 mg/d
Pregnancy, breast-feeding or child-bearing potential
History of poor adherence to hemodialysis or medical regimen
Inability to provide consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37323

Other trials in United States

About this study

Official title: Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 2

Little is known about how some drugs affect inflammation or clotting factors in people receiving hemodialysis. It is not yet known if these drugs help prevent heart damage as they do in people not undergoing hemodialysis or whether they could increase the risk of heart problems. The purpose of the study is to measure certain chemicals in the blood and see how those chemicals may change during hemodialysis when certain drugs are given.

Read the detailed description

Cardiovascular disease in the leading cause of death in patients with chronic kidney disease undergoing hemodialysis.
Traditional risk factors do not adequately predict cardiovascular morbidity and mortality in patients with chronic kidney disease.
Increased oxidative stress, inflammation and impaired fibrinolysis contribute to cardiovascular risk in chronic kidney disease patients undergoing hemodialysis.
Activation of the renin-angiotensin-aldosterone system(RAAS) may contribute to oxidative stress and inflammation in individuals with chronic kidney disease
Activation of the kallikrein-kinin system during hemodialysis may increase fibrinolysis but may also contribute to inflammation in chronic kidney disease
Despite data from clinical trials demonstrating that ARBs and ACE inhibitors decrease cardiovascular mortality, delay progression to cardiovascular disease and decrease the incidence of diabetes in the general population little is known about the impact of these agents on cardiovascular morbidity and mortality in patients with end- stage renal disease (ESRD) undergoing hemodialysis
Angiotensin-converting enzyme(ACE) inhibitors and angiotensin receptor blockers (ARB)S differ in their mechanisms of action and their effects on inflammatory biomarkers

Conditions: End Stage Renal Failure on Dialysis, Complication of Hemodialysis
Being tested: Placebo, Ramipril, Valsartan
Keywords: hemodialysis, oxidative stress, inflammation, kallikrein-kinin, angiotensin receptor blockade, angiotensin converting enzyme inhibition, RAAS, fibrinolysis, endothelial dysfunction
Medical subject headings: Inflammation

What participants receive

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

PlaceboDrug
Also called matching placebo
Patients receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker before the study underwent washout for 3 weeks. Subjects were treated with study drug for 7 days and each treatment period was separated by a 3-week washout period. Ramipril was given at dose of 2.5mg/d for two days, then 5mg/d for 5 days. Valsartan was given at 80mg/d for 2 days followed by 160mg/d for 5 days. On the seventh day of each treatment blood samples were collected prior two, during and two hours after dialysis
RamiprilDrug
Also called Ramipril 2.5mg/d for two days, then 5mg/d for 5 days.
Patients receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker before the study underwent washout for 3 weeks. Subjects were treated with study drug for 7 days and each treatment period was separated by a 3-week washout period. Ramipril was given at dose of 2.5mg/d for two days, then 5mg/d for 5 days. Valsartan was given at 80mg/d for 2 days followed by 160mg/d for 5 days. On the seventh day of each treatment blood samples were collected prior two, during and two hours after dialysis
ValsartanDrug
Also called Valsartan 80mg/d for 2 days followed by 160mg/d for 5 days.
Patients receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker before the study underwent washout for 3 weeks. Subjects were treated with study drug for 7 days and each treatment period was separated by a 3-week washout period. Ramipril was given at dose of 2.5mg/d for two days, then 5mg/d for 5 days. Valsartan was given at 80mg/d for 2 days followed by 160mg/d for 5 days. On the seventh day of each treatment blood samples were collected prior two, during and two hours after dialysis

Study groups in NCT00732069
Study group	Role	What they receive
Placebo, then ramipril, then valsartan	Active comparator	placebo, ramipril, valsartan: Subjects were treated sequentially with placebo, ramipril (5mg/day by mouth), then valsartan (160mg/day by mouth). Each drug was given for 7 days after a 3-week washout. Receives: Drug: Placebo; Drug: Ramipril; Drug: Valsartan
Placebo, then valsartan, then ramipril	Active comparator	placebo, ramipril, valsartan: Subjects were treated sequentially with placebo, valsartan (160mg/day by mouth), then ramipril (5mg/day by mouth). Each drug was given for 7 days after a 3-week washout. Receives: Drug: Placebo; Drug: Ramipril; Drug: Valsartan
Ramipril, then placebo, then valsartan	Active comparator	placebo, ramipril, valsartan: Subjects were treated sequentially with ramipril (5mg/day by mouth), then placebo (once a day by mouth), then valsartan (160mg/day by mouth). Each drug was given for 7 days after a 3-week washout. Receives: Drug: Placebo; Drug: Ramipril; Drug: Valsartan
Valsartan, then placebo, then ramipril	Active comparator	placebo, ramipril, valsartan: Subjects were treated sequentially with valsartan (160mg/day by mouth), then placebo (once a day by mouth), then ramipril (5mg/day by mouth). Each drug was given for 7 days after a 3-week washout. Receives: Drug: Placebo; Drug: Ramipril; Drug: Valsartan
Ramipril, then valsartan, then placebo	Active comparator	placebo, ramipril, valsartan: Subjects were treated sequentially with ramipril (5mg/day by mouth), then valsartan (160mg/day by mouth), then placebo (once a day by mouth). Each drug was given for 7 days after a 3-week washout. Receives: Drug: Placebo; Drug: Ramipril; Drug: Valsartan
Valsartan, then ramipril, then placebo	Active comparator	placebo, ramipril, valsartan: Subjects were treated sequentially with then valsartan (160mg/day by mouth), then ramipril (5mg/day by mouth), then placebo (once a day by mouth). Each drug was given for 7 days after a 3-week washout. Receives: Drug: Placebo; Drug: Ramipril; Drug: Valsartan

What is being measured

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

Interleukin 1 Beta
Mean difference in interleukin 1 beta concentration during treatment with ramipril versus treatment with placebo
Measured: During dialysis after one week of study drug

Secondary outcomes (1)

F2-Isoprostanes
Mean difference in F2-isoprostanes during dialysis between treatment with ramipril or valsartan and placebo
Measured: During dialysis after one week of study drug

Timeline

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

Aug 2008Dec 2011

First posted11 Aug 2008 (estimated)
Study startAug 2008
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for End Stage Renal Failure on DialysisStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00732069
Sponsor's protocol ID: Fibrinolysis in Dialysis
Other IDs: R01HL065193-08A2
Status last verified: Jun 2013
First submitted: 6 Aug 2008
Last updated: 2 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Gamboa JL, Pretorius M, Todd-Tzanetos DR, Luther JM, Yu C, Ikizler TA, Brown NJ. Comparative effects of angiotensin-converting enzyme inhibition and angiotensin-receptor blockade on inflammation during hemodialysis. J Am Soc Nephrol. 2012 Feb;23(2):334-42. doi: 10.1681/ASN.2011030287. Epub 2011 Dec 8.
PubMed 22158433
Gamboa JL, Pretorius M, Sprinkel KC, Brown NJ, Ikizler TA. Angiotensin converting enzyme inhibition increases ADMA concentration in patients on maintenance hemodialysis--a randomized cross-over study. BMC Nephrol. 2015 Oct 22;16:167. doi: 10.1186/s12882-015-0162-x.
PubMed 26494370

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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RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
RecruitingPhase 2
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All End Stage Renal Failure on Dialysis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 2
ClinicalTrials.gov ID: NCT00732069
Acronym / sponsor ID: Fibrinolysis in Dialysis
Conditions: End Stage Renal Failure on Dialysis, Complication of Hemodialysis
Keywords: hemodialysis, oxidative stress, inflammation, kallikrein-kinin, angiotensin receptor blockade, angiotensin converting enzyme inhibition, RAAS, fibrinolysis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Vanderbilt UniversityUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Aug 2008
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 11 Aug 2008 (estimated)
Results: Posted 20 Jun 2013

Clinical summary

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

Detailed description

Cardiovascular disease in the leading cause of death in patients with chronic kidney disease undergoing hemodialysis.
Traditional risk factors do not adequately predict cardiovascular morbidity and mortality in patients with chronic kidney disease.
Increased oxidative stress, inflammation and impaired fibrinolysis contribute to cardiovascular risk in chronic kidney disease patients undergoing hemodialysis.
Activation of the renin-angiotensin-aldosterone system(RAAS) may contribute to oxidative stress and inflammation in individuals with chronic kidney disease
Activation of the kallikrein-kinin system during hemodialysis may increase fibrinolysis but may also contribute to inflammation in chronic kidney disease
Despite data from clinical trials demonstrating that ARBs and ACE inhibitors decrease cardiovascular mortality, delay progression to cardiovascular disease and decrease the incidence of diabetes in the general population little is known about the impact of these agents on cardiovascular morbidity and mortality in patients with end- stage renal disease (ESRD) undergoing hemodialysis
Angiotensin-converting enzyme(ACE) inhibitors and angiotensin receptor blockers (ARB)S differ in their mechanisms of action and their effects on inflammatory biomarkers

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Placebo, then ramipril, then valsartan	Active comparator	Drug: Placebo, Drug: Ramipril, Drug: Valsartanplacebo, ramipril, valsartan: Subjects were treated sequentially with placebo, ramipril (5mg/day by mouth), then valsartan (160mg/day by mouth). Each drug was given for 7 days after a 3-week washout.
Placebo, then valsartan, then ramipril	Active comparator	Drug: Placebo, Drug: Ramipril, Drug: Valsartanplacebo, ramipril, valsartan: Subjects were treated sequentially with placebo, valsartan (160mg/day by mouth), then ramipril (5mg/day by mouth). Each drug was given for 7 days after a 3-week washout.
Ramipril, then placebo, then valsartan	Active comparator	Drug: Placebo, Drug: Ramipril, Drug: Valsartanplacebo, ramipril, valsartan: Subjects were treated sequentially with ramipril (5mg/day by mouth), then placebo (once a day by mouth), then valsartan (160mg/day by mouth). Each drug was given for 7 days after a 3-week washout.
Valsartan, then placebo, then ramipril	Active comparator	Drug: Placebo, Drug: Ramipril, Drug: Valsartanplacebo, ramipril, valsartan: Subjects were treated sequentially with valsartan (160mg/day by mouth), then placebo (once a day by mouth), then ramipril (5mg/day by mouth). Each drug was given for 7 days after a 3-week washout.
Ramipril, then valsartan, then placebo	Active comparator	Drug: Placebo, Drug: Ramipril, Drug: Valsartanplacebo, ramipril, valsartan: Subjects were treated sequentially with ramipril (5mg/day by mouth), then valsartan (160mg/day by mouth), then placebo (once a day by mouth). Each drug was given for 7 days after a 3-week washout.
Valsartan, then ramipril, then placebo	Active comparator	Drug: Placebo, Drug: Ramipril, Drug: Valsartanplacebo, ramipril, valsartan: Subjects were treated sequentially with then valsartan (160mg/day by mouth), then ramipril (5mg/day by mouth), then placebo (once a day by mouth). Each drug was given for 7 days after a 3-week washout.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age 18 years or older
On thrice-weekly chronic hemodialysis for at least 6 months
Clinically stable, adequately dialyzed (single-pool Kt/V> 1.2) thrice weekly, with polysulphone membrane for at least 3 consecutive months prior to study

Key exclusion criteria (19 listed)

Body mass index > 35 mg/kg
History of functional transplant less than 6 months prior to study
Use of anti-inflammatory medications other than aspirin < 325 mg/d
History of active connective tissue disease
History of acute infectious disease within one month prior to study

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
PlaceboAlso: matching placeboPatients receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker before the study underwent washout for 3 weeks. Subjects were treated with study drug for 7 days and each treatment period was separated by a 3-week washout period. Ramipril was given at dose of 2.5mg/d for two days, then 5mg/d for 5 days. Valsartan was given at 80mg/d for 2 days followed by 160mg/d for 5 days. On the seventh day of each treatment blood samples were collected prior two, during and two hours after dialysis	Drug	Placebo, then ramipril, then valsartan, Placebo, then valsartan, then ramipril, Ramipril, then placebo, then valsartan, Ramipril, then valsartan, then placebo, Valsartan, then placebo, then ramipril, Valsartan, then ramipril, then placebo
RamiprilAlso: Ramipril 2.5mg/d for two days, then 5mg/d for 5 days.Patients receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker before the study underwent washout for 3 weeks. Subjects were treated with study drug for 7 days and each treatment period was separated by a 3-week washout period. Ramipril was given at dose of 2.5mg/d for two days, then 5mg/d for 5 days. Valsartan was given at 80mg/d for 2 days followed by 160mg/d for 5 days. On the seventh day of each treatment blood samples were collected prior two, during and two hours after dialysis	Drug	Placebo, then ramipril, then valsartan, Placebo, then valsartan, then ramipril, Ramipril, then placebo, then valsartan, Ramipril, then valsartan, then placebo, Valsartan, then placebo, then ramipril, Valsartan, then ramipril, then placebo
ValsartanAlso: Valsartan 80mg/d for 2 days followed by 160mg/d for 5 days.Patients receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker before the study underwent washout for 3 weeks. Subjects were treated with study drug for 7 days and each treatment period was separated by a 3-week washout period. Ramipril was given at dose of 2.5mg/d for two days, then 5mg/d for 5 days. Valsartan was given at 80mg/d for 2 days followed by 160mg/d for 5 days. On the seventh day of each treatment blood samples were collected prior two, during and two hours after dialysis	Drug	Placebo, then ramipril, then valsartan, Placebo, then valsartan, then ramipril, Ramipril, then placebo, then valsartan, Ramipril, then valsartan, then placebo, Valsartan, then placebo, then ramipril, Valsartan, then ramipril, then placebo

Primary outcome

Interleukin 1 Beta
Time frame: During dialysis after one week of study drug
Mean difference in interleukin 1 beta concentration during treatment with ramipril versus treatment with placebo

1 secondary outcome

F2-Isoprostanes
Time frame: During dialysis after one week of study drug

Results and safety

Results posted to the registry on 20 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo, Then Ramipril, Then Valsartan	3	3
Placebo, Valsartan, Then Ramipril	3	3
Ramipril, Then Placebo, Then Valsartan	3	3
Valsartan, Then Placebo, Then Ramipril	2	2
Ramipril, Valsartan, Then Placebo	3	3
Valsartan, Ramipril, Then Placebo	2	2

Primary outcome: Interleukin 1 Beta

Time frame: During dialysis after one week of study drug. Mean (Standard Error). Unit: pg/mL

Measure	Ramipril n = 15	Valsartan n = 15	Placebo n = 15
Value	6.18 (3.56)	2.16 (2.16)	1.44 (1.49)

Population analysed: All participants who completed the three arm treatment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ramipril	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
Valsartan	0 of 15 (0%)	4 of 15 (26.7%)	Not reported
Placebo	1 of 16 (6.3%)	7 of 15 (46.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22158433Gamboa JL, Pretorius M, Todd-Tzanetos DR, Luther JM, Yu C, Ikizler TA, Brown NJ. Comparative effects of angiotensin-converting enzyme inhibition and angiotensin-receptor blockade on inflammation during hemodialysis. J Am Soc Nephrol. 2012 Feb;23(2):334-42. doi: 10.1681/ASN.2011030287. Epub 2011 Dec 8.
Derived from this study: PubMed 26494370Gamboa JL, Pretorius M, Sprinkel KC, Brown NJ, Ikizler TA. Angiotensin converting enzyme inhibition increases ADMA concentration in patients on maintenance hemodialysis--a randomized cross-over study. BMC Nephrol. 2015 Oct 22;16:167. doi: 10.1186/s12882-015-0162-x.

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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.

Nancy J Brown, MD principal investigator

Vanderbilt University Medical Center

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ramipril and Valsartan in people with End Stage Renal Failure on Dialysis and Complication of Hemodialysis, run by Vanderbilt University at 1 site in United States.

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 3 inclusion and 19 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: finished, as of the sponsor's last update on 2 Jul 2013. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Interleukin 1 Beta (time frame: During dialysis after one week of study drug). 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 NCT00732069, which also lists 2 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 Jul 2013.