Renal FailurePhase 4MACHTNCT00839358

Effect of Midodrine and Albumine in the Prevention of Complications in Cirrhotic Patients Awaiting Liver Transplantation

A Phase 4 study testing albumin and Midodrine in people with Renal Failure and Hyponatremia, run by Hospital Clinic of Barcelona at 1 site in Spain.

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 to 70 years
Conditions the study is for: Renal Failure, Hyponatremia, Sepsis
What is being tested?: albumin and Midodrine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 199 participants
Where: 1 siteSpain
Study dates: Aug 2008to Feb 2016
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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with cirrhosis in the waiting list for liver transplant
Patients with ascites or diuretic treatment
To have written inform consent

Who cannot join

Systolic blood pressure ≥150 mmHg and or diastolic blood pressure≥90 mmHg
To have been treated with transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunts
Antibiotic treatment in the previous week before the inclusion in the study
Respiratory or cardiac failure
HIV positive

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Clinic
Villarroel 170, Barcelona, 08870

Other trials in Spain

About this study

Official title: Midodrine and Albumin for Cirrhotic Patients in the Waiting List for Liver Transplantation

The aim of this study is to evaluate the effect of prolonged administration of albumin and midodrine on the prevention of complications (renal failure, sepsis, hemorrhage, hepatic encephalopathy and hyponatremia) in patients with cirrhosis in the waiting list for liver transplantation. One hundred and ninety four patients with cirrhosis and awaiting a liver transplantation will include in the study. Patients will be randomized to receive albumin and midodrine (treatment group) or administration of placebo (saline for albumine) and tablets with excipients without midodrine (control group). Patients will be followed-up during 12th months. In the treatment group albumin will be given at a dose of 40g every 15 days and midodrine 5mg tid, in addition with lactitol (conventional doses) and the specific treatment that patients require by cirrhosis. The group control will receive placebo in the same way than the treatment group in addition with lactitol and the specific treatment that they require by their disease. In all the patients liver and renal function test, hormones determination (renin, aldosterone, noradrenaline), and cytokines will be determined in basal conditions. All these determinations will be repeated at month 1st,3rd, 6th and 12th months. Before the inclusion in the study neuropsychological test and critical flicker test will be performed to diagnose minimum EH. These tests will be repeated at 3rd, 6th and 12th months. All the determinations will be repeated at any time that the patients develop any complication considered as an end point. In baseline conditions and at 3rd and 6th months a questionnaire of quality of life (SF36) will be performed. During a year of follow-up the number of paracentesis that patients require, the incidence of renal failure and EH and their relationship with hormonal activity and cytokine levels, free transplant survival and quality of life will be recorded.

Read the detailed description

End point: To evaluate the effect of long term administration of albumin and midodrine on the prevention of complications associated with cirrhosis in patients with cirrhosis awaiting for liver transplantation.

Secondary end points:

To evaluate improvement in the ascites control
To evaluate survival at 6 and 12 months.
To evaluate the relationship between the development of complications and the activity of vasoconstrictor systems( renin, aldosterone and norepinephrine) as well as the levels of cytokines (TNF, IL6 and IL10)
To evaluate quality of life
To evaluate the presence and outcome of MHE

Conditions: Renal Failure, Hyponatremia, Sepsis, Hepatic Encephalopathy, Gastrointestinal Bleeding
Being tested: albumin, Midodrine, Placebo
Keywords: cirrhosis, renal failure, midodrine, albumine
Medical subject headings: Renal Insufficiency, Hyponatremia, Sepsis, Hepatic Encephalopathy, Gastrointestinal Hemorrhage, Fibrosis

What participants receive

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

albuminDrug
Also called Albumina Grifols
albumine 40 g every 15 days
MidodrineDrug
Also called Gutron
Midodrine 5mg/8 hs, can be increase up to 8mg/8hs if there is a lack of increase in at least 10mmHg in mean arterial pressure after 15 days of treatment.
PlaceboDrug
Also called Grifols saline solution
saline solution

Study groups in NCT00839358
Study group	Role	What they receive
Albumin plus midodrine	Active comparator	Albumin 40 g every 15 days during 1 year or until liver transplantation. Midodrine 5mg/8h. It can be increased according the value of mean arterial pressure. If there is no increase (defined as at least 10mmHGin MAP)midodrine can be increased at a dose of 10mg/8h. This treatment will be given during 1 year or until liver transplantation. Receives: Drug: albumin; Drug: Midodrine
salin solution plus pills	Placebo comparator	Placebo of albumin in the same schedule thats in arm 1; placebo of midodrine in the same schedule thats in arm 1. Receives: Drug: albumin; Drug: Placebo

What is being measured

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

To evaluate complications (renal failure, hepatic encephalopathy, hyponatremia, infection and gastrointestinal bleeding) in patients with cirrhosis awaiting for liver transplant.
Measured: When 97 patients are included (% of the whole population)

Timeline

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

Aug 2008Feb 2016

First posted9 Feb 2009 (estimated)
Study startAug 2008
Primary completionFeb 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Renal FailureStudies of the same condition, open and under way.
More trials run by Hospital Clinic of BarcelonaThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 199 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00839358
Sponsor's protocol ID: MACHT
Other IDs: 07/0443, 07/90077
Acronym: MACHT
Status last verified: Aug 2016
First submitted: 6 Feb 2009
Last updated: 18 Aug 2016
Results posted: No
Data monitoring committee: Yes

Publications

Alessandria C, Debernardi-Venon W, Carello M, Ceretto S, Rizzetto M, Marzano A. Midodrine in the prevention of hepatorenal syndrome type 2 recurrence: a case-control study. Dig Liver Dis. 2009 Apr;41(4):298-302. doi: 10.1016/j.dld.2008.09.014. Epub 2009 Jan 20.
PubMed 19158001
Martin-Llahi M, Pepin MN, Guevara M, Diaz F, Torre A, Monescillo A, Soriano G, Terra C, Fabrega E, Arroyo V, Rodes J, Gines P; TAHRS Investigators. Terlipressin and albumin vs albumin in patients with cirrhosis and hepatorenal syndrome: a randomized study. Gastroenterology. 2008 May;134(5):1352-9. doi: 10.1053/j.gastro.2008.02.024. Epub 2008 Feb 14.
PubMed 18471512
Wong F, Pantea L, Sniderman K. Midodrine, octreotide, albumin, and TIPS in selected patients with cirrhosis and type 1 hepatorenal syndrome. Hepatology. 2004 Jul;40(1):55-64. doi: 10.1002/hep.20262.
PubMed 15239086
Salerno F, Gerbes A, Gines P, Wong F, Arroyo V. Diagnosis, prevention and treatment of hepatorenal syndrome in cirrhosis. Gut. 2007 Sep;56(9):1310-8. doi: 10.1136/gut.2006.107789. Epub 2007 Mar 27. No abstract available.
PubMed 17389705
Guevara M, Gines P. Hepatorenal syndrome. Dig Dis. 2005;23(1):47-55. doi: 10.1159/000084725.
PubMed 15920325
Sola E, Sole C, Simon-Talero M, Martin-Llahi M, Castellote J, Garcia-Martinez R, Moreira R, Torrens M, Marquez F, Fabrellas N, de Prada G, Huelin P, Lopez Benaiges E, Ventura M, Manriquez M, Nazar A, Ariza X, Sune P, Graupera I, Pose E, Colmenero J, Pavesi M, Guevara M, Navasa M, Xiol X, Cordoba J, Vargas V, Gines P. Midodrine and albumin for prevention of complications in patients with cirrhosis awaiting liver transplantation. A randomized placebo-controlled trial. J Hepatol. 2018 Dec;69(6):1250-1259. doi: 10.1016/j.jhep.2018.08.006. Epub 2018 Aug 21.
PubMed 30138685

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?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Midodrine and Albumin for Cirrhotic Patients in the Waiting List for Liver Transplantation
ClinicalTrials.gov ID: NCT00839358
Acronym / sponsor ID: MACHT / MACHT
Conditions: Renal Failure, Hyponatremia, Sepsis, Hepatic Encephalopathy, Gastrointestinal Bleeding
Keywords: cirrhosis, renal failure, midodrine, albumine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 199 participants (actual)
Lead sponsor: Hospital Clinic of BarcelonaUniversity, hospital or other
Collaborators: Maternal-Infantil Vall d´Hebron Hospital, Hospital Universitari de Bellvitge
Study start: Aug 2008
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 9 Feb 2009 (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

Secondary end points:

To evaluate improvement in the ascites control
To evaluate survival at 6 and 12 months.
To evaluate the relationship between the development of complications and the activity of vasoconstrictor systems( renin, aldosterone and norepinephrine) as well as the levels of cytokines (TNF, IL6 and IL10)
To evaluate quality of life
To evaluate the presence and outcome of MHE

Study design

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

Arm	Type	Receives
Albumin plus midodrine	Active comparator	Drug: albumin, Drug: MidodrineAlbumin 40 g every 15 days during 1 year or until liver transplantation. Midodrine 5mg/8h. It can be increased according the value of mean arterial pressure. If there is no increase (defined as at least 10mmHGin MAP)midodrine can be increased at a dose of 10mg/8h. This treatment will be given during 1 year or until liver transplantation.
salin solution plus pills	Placebo comparator	Drug: albumin, Drug: PlaceboPlacebo of albumin in the same schedule thats in arm 1; placebo of midodrine in the same schedule thats in arm 1.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with cirrhosis in the waiting list for liver transplant
Patients with ascites or diuretic treatment
To have written inform consent

Key exclusion criteria (5 listed)

Systolic blood pressure ≥150 mmHg and or diastolic blood pressure≥90 mmHg
To have been treated with transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunts
Antibiotic treatment in the previous week before the inclusion in the study
Respiratory or cardiac failure
HIV positive

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
albuminAlso: Albumina Grifolsalbumine 40 g every 15 days	Drug	Albumin plus midodrine, salin solution plus pills
MidodrineAlso: GutronMidodrine 5mg/8 hs, can be increase up to 8mg/8hs if there is a lack of increase in at least 10mmHg in mean arterial pressure after 15 days of treatment.	Drug	Albumin plus midodrine
PlaceboAlso: Grifols saline solutionsaline solution	Drug	salin solution plus pills

Primary outcome

To evaluate complications (renal failure, hepatic encephalopathy, hyponatremia, infection and gastrointestinal bleeding) in patients with cirrhosis awaiting for liver transplant.
Time frame: When 97 patients are included (% of the whole population)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
Background: PubMed 19158001Alessandria C, Debernardi-Venon W, Carello M, Ceretto S, Rizzetto M, Marzano A. Midodrine in the prevention of hepatorenal syndrome type 2 recurrence: a case-control study. Dig Liver Dis. 2009 Apr;41(4):298-302. doi: 10.1016/j.dld.2008.09.014. Epub 2009 Jan 20.
Background: PubMed 18471512Martin-Llahi M, Pepin MN, Guevara M, Diaz F, Torre A, Monescillo A, Soriano G, Terra C, Fabrega E, Arroyo V, Rodes J, Gines P; TAHRS Investigators. Terlipressin and albumin vs albumin in patients with cirrhosis and hepatorenal syndrome: a randomized study. Gastroenterology. 2008 May;134(5):1352-9. doi: 10.1053/j.gastro.2008.02.024. Epub 2008 Feb 14.
Background: PubMed 15239086Wong F, Pantea L, Sniderman K. Midodrine, octreotide, albumin, and TIPS in selected patients with cirrhosis and type 1 hepatorenal syndrome. Hepatology. 2004 Jul;40(1):55-64. doi: 10.1002/hep.20262.
Background: PubMed 17389705Salerno F, Gerbes A, Gines P, Wong F, Arroyo V. Diagnosis, prevention and treatment of hepatorenal syndrome in cirrhosis. Gut. 2007 Sep;56(9):1310-8. doi: 10.1136/gut.2006.107789. Epub 2007 Mar 27. No abstract available.
Background: PubMed 15920325Guevara M, Gines P. Hepatorenal syndrome. Dig Dis. 2005;23(1):47-55. doi: 10.1159/000084725.
Derived from this study: PubMed 30138685Sola E, Sole C, Simon-Talero M, Martin-Llahi M, Castellote J, Garcia-Martinez R, Moreira R, Torrens M, Marquez F, Fabrellas N, de Prada G, Huelin P, Lopez Benaiges E, Ventura M, Manriquez M, Nazar A, Ariza X, Sune P, Graupera I, Pose E, Colmenero J, Pavesi M, Guevara M, Navasa M, Xiol X, Cordoba J, Vargas V, Gines P. Midodrine and albumin for prevention of complications in patients with cirrhosis awaiting liver transplantation. A randomized placebo-controlled trial. J Hepatol. 2018 Dec;69(6):1250-1259. doi: 10.1016/j.jhep.2018.08.006. Epub 2018 Aug 21.

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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.

Pere Ginès principal investigator

Hospital Clinic of Barcelona

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 albumin and Midodrine in people with Renal Failure and Hyponatremia, run by Hospital Clinic of Barcelona at 1 site in Spain.

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 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: finished, as of the sponsor's last update on 18 Aug 2016. 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 Spain. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To evaluate complications (renal failure, hepatic encephalopathy, hyponatremia, infection and gastrointestinal bleeding) in patients with cirrhosis awaiting for liver transplant. (time frame: When 97 patients are included (% of the whole population)). 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 NCT00839358, which also lists 6 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 18 Aug 2016.