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Lanreotide In Polycystic Kidney Disease Study
Plain-language guide to NCT02127437: phase 3 randomized trial of Lanreotide, 159 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02127437
- Phase
- phase 3
- Status
- completed
- Start
- 2014-09-19
- Completion (planned or actual)
- 2019-07-31
- Participants
- 159 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Autosomal Dominant Polycystic Kidney Disease (ADPKD
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Lanreotide.
LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized double blind placebo controlled study.
Cardiovascular outcomes, blood pressure, quality of life and safety are among the secondary outcomes.
It had two arms (groups): A - treated group (experimental) and B - control group (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 159 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Autosomal dominant polycystic kidney disease (clinical, familial, imaging grounds). Age \> 18. Affiliated with health insurance. Written informed consent.
The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: iohexol /iodine allergy; diabetes mellitus; other associated nephropathy suspected.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
The participants were allocated by chance, so the Lanreotide group and the comparison group should start out alike.
The Lanreotide group and the comparison group ran side by side rather than switching.
As a double-blind Lanreotide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2014-09-19 with completion listed for 2019-07-31.
It ran at 1 site in France.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Glomerular filtration rate (GFR) (time frame: month 36).
It also tracked 9 secondary outcomes, for example Glomerular filtration rate (GFR), Glomerular filtration rate (GFR) decline, Safety, tolerance, Onset or worsening of hypertension, Onset or worsening of hypertension and Quality of life.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Lanreotide in 159 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Lanreotide compound page, all human trials.
Our Notes on the Compound
Lanreotide: A long-acting 8-amino-acid somatostatin analog (Somatuline Depot) in the same class as octreotide.
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.