Somatostatin in Polycystic Kidney: a Long-term Three Year Follow up Study

What Was Tested

In this phase 3 trial, researchers set out to test Somatostatin.

A reasonable explanation for the above findings is that in ADPKD progression is largely dependent on the development and growth of cysts and secondary disruption of normal tissue.

It had two arms (groups): somatostatin (experimental) and Saline solution (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

The fluid filling renal cysts in human polycystic kidney is formed mainly by a secretion process of the tubular epithelium lining the cysts.

The same process, via the secondary active chloride transport, is also involved in the secretion of fluid into the lumen of proximal tubules in teleost and elasmobranch fishes.

Recently, somatostatin analogues have become available and used with negligible side effects for long-term treatment of tumors (up to 8-12 months).

To evaluate the tolerability and the safety of long-acting somatostatin in ADPKD patients, a prospective cross-over controlled study has been recently performed.

Who Took Part

78 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Clinical and ultrasound diagnosis of ADPKD. Written informed consent.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: urinary tract lithiasis, infection or obstruction.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Random assignment meant chance, not the researchers, decided who got Somatostatin and who got the comparison, which limits bias.

The Somatostatin group and the comparison group ran side by side rather than switching.

In this single-blind Somatostatin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2006-04 with completion listed for 2012-01.

It ran at 5 sites in Italy (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change over baseline of the total kidney volume at 1 and 3 years follow-up (estimated by gadolinium contrast enhanced and T2-weighted magnetic resonance imaging, MRI) (time frame: Basal, 1 and 3 years follow-up).

It also tracked 4 secondary outcomes, for example Total renal parenchymal volume, Residual renal volume and Renal parenchymal volume taken up by small cysts, minor of five mmcubic.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Somatostatin in 78 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Somatostatin compound page, all human trials.