NCT02119052

Effect of Long-acting Somatostatin on Liver in Autosomal Dominant Polycystic Kidney Disease

Completed Phase 2/Phase 3 Last updated 18 April 2014

What this trial tests

Phase 2/Phase 3 trial testing octeotride in Autosomal Dominant Polycystic Kidney Disease in 35 participants. Completed.

Timeline

1 January 2009

Primary endpoint
1 September 2013

Quick facts

Lead sponsor	Federico II University
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	35
Start date	1 January 2009
Primary completion	1 September 2013

Drugs / interventions tested

• octeotride — full drug profile →
• placebo

Conditions studied

• Autosomal Dominant Polycystic Kidney Disease — all drugs for Autosomal Dominant Polycystic Kidney Disease →

Sponsor

Federico II University

Who can join

18 and older, any sex, with Autosomal Dominant Polycystic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Effect of somatostatin on liver volume
  Time frame: 3 years

Sponsor's own description

Autosomal dominant polycystic kidney disease (ADPKD) is associated with the development of a variety of extrarenal manifestations of which polycystic liver disease is most common. The investigators aimed to assess the changes over time of liver volume in ADPKD patients and whether it is affected by the treatment with the somatostatin analogue, octreotide.

35 ADPKD patients (14 males) aged 34±8 years were randomly assigned to 36 month treatment with placebo (n=18) or octreotide (n=17). Clinical and liver parameters at magnetic resonance (RM) were evaluated at baseline, study end and after 24 months of drug withdrawal.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Long-term Effects of Octreotide on Liver Volume in Patients With Polycystic Kidney and Liver Disease.
   Pisani A, Sabbatini M, Imbriaco M, Riccio E, et al · · 2016 · cited 46× · PMID 26844873 · DOI 10.1016/j.cgh.2015.12.049
2. Experimental Models of Polycystic Kidney Disease: Applications and Therapeutic Testing.
   Sieben CJ, Harris PC. · · 2023 · cited 23× · PMID 37418622 · DOI 10.34067/kid.0000000000000209
3. Clinical manifestation, epidemiology, genetic basis, potential molecular targets, and current treatment of polycystic liver disease.
   Mahboobipour AA, Ala M, Safdari Lord J, Yaghoobi A. · · 2024 · cited 7× · PMID 38671465 · DOI 10.1186/s13023-024-03187-w