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Midodrine, Octreotide and Albumin: Impact on Renal Function of Patients With Liver Cirrhosis and Renal Failure
Plain-language guide to NCT01587222: phase 2 interventional trial of Octreotide. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01587222
- Phase
- phase 2
- Status
- withdrawn
- Start
- 2016-07
- Completion (planned or actual)
- 2017-07
- Participants
- n/a (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Fibrosis; Renal Failure; Hepatorenal Syndrome
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Octreotide.
The aim of this study is to evaluate the treatment with midodrine, octreotide and albumin during 12 weeks in patients with hepatorenal syndrome.
Fifteen patients will be enrolled and followed during 16 weeks.
The effects on renal function will be evaluated 12 and 16 weeks after the beginning of the treatment by isotopic evidence and biochemist determinations.
It had 1 arm (groups): Albumin, Midodrine, Octreotide (experimental).
The registry classes the interventions as drug.
Who Took Part
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age between 18 and 80 years. Cirrhosis of the liver defined by clinical, biochemical or histological. That, properly informed, give their consent to participate in the study and undergo tests and examinations that entails.
The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: pregnant women, nursing mothers, or those who intend to become pregnant during the study period; systolic blood pressure ≥ 150 mmhg and / or diastolic blood pressure ≥ 90 mmhg; previous treatment with transjugular intrahepatic portosystemic shunt (tips) or surgical portosystemic shunts.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the Octreotide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2016-07 with completion listed for 2017-07.
It ran at 1 site in Spain.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Glomerular filtration (time frame: 12 weeks).
It also tracked 3 secondary outcomes, for example Changes in plasma renin activity, plasma aldosterone and norepinephrine, Changes in blood pressure measured by Holter and Changes in renal function.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Octreotide in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Octreotide compound page, all human trials.
Our Notes on the Compound
Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.