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Trial · Interventional

Active, not recruitingPhase 2/3Results postedRegistry data

A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD

Short name POSITANO

NCTNCT05281328 (opens ClinicalTrials.gov in a new tab)Other idHS-20-677Other id2021-003764-27
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 2/3
Enrollment
71 participants (actual)
Sponsor
Camurus AB · Industry
Design
Randomized · Quadruple masking
Countries
4 countries

United States, Belgium, Germany, Netherlands

Start
28 Jun 2022
Primary completion
5 Feb 2025
Completion
Aug 2027 (estimated)
First posted
16 Mar 2022
Last update posted
1 Jun 2026
Conditions
Polycystic Liver Disease

Timeline

1 trial · 1 ongoing · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025202620272028
  1. Ph 2/3

    POSITANO

    NCT05281328

    28 Jun 2022 to est. Aug 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of the trial is to compare the effectiveness and safety of 2 treatment regimens of CAM2029 (given weekly or every 2 weeks) to placebo in participants with symptomatic PLD, either isolated as in autosomal dominant PLD (ADPLD) or associated with autosomal dominant polycystic kidney disease (ADPKD). In the Treatment Period of the trial, participants will be allocated at random to 1 of the 3 treatment arms in a 1:1:1 ratio. After completing the Treatment Period (53 weeks) participants may proceed to a 120-week open-label extension part of the trial and then only receive the same CAM2029 treatment. The active ingredient in CAM2029, octreotide, is administered as a subcutaneous depot using Camurus' FluidCrystal® technology.

Interventions

  • CAM2029Drug
  • PlaceboDrug

Arms3

  • Experimental

    CAM2029 once weekly

    0.5 mL CAM2029 10 mg, subcutaneous (SC) injection, once weekly

  • Experimental

    CAM2029 once every 2 weeks

    0.5 mL CAM2029 10 mg, SC injection, every 2 weeks and 0.5 mL placebo, SC injection, once every 2 weeks (alternating with CAM2029 dosing)

  • Placebo comparator

    Placebo

    0.5 mL placebo, SC injection, once weekly

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Height-adjusted Total Liver Volume (htTLV)

    Time frame · From screening until treatment week 53

    Registry description

    Magnetic resonance imaging (MRI) was used to measure the total liver volume (TLV) at baseline and at Week 53 and was adjusted to the participant's height. The change from baseline to Week 53 was calculated as the difference between htTLV values at Week 53 and baseline. The difference in treatment effect between the groups was presented as a ratio expressed in percentage.

Secondary outcomes(13)

  1. PLD Symptom (PLD-S) Score

    Time frame · From screening to Week 53

    Registry description

    Change from baseline to Week 53 in the PLD-S measure score.

  2. htTLV

    Time frame · From screening until treatment weeks 13, 25, 77, 125 and 173

    Registry description

    Change from baseline in htTLV as determined by MRI volumetry

  3. PLD-S

    Time frame · From screening to weeks 13, 21, 25, 39, 77, 101, 125, 149 and 173

    Registry description

    Change from baseline in the PLD-S measure score

  4. Height-adjusted Total Kidney Volume (htTKV)

    Time frame · From screening until treatment weeks 13, 25, 53, 77, 125 and 173

    Registry description

    Change from baseline in htTKV as determined by MRI volumetry

  5. Total Liver Cyst Volume

    Time frame · From screening to treatment weeks 13, 25, 53, 77, 125 and 173

    Registry description

    Change from baseline in total liver cyst volume determined by MRI volumetry

  6. Estimated Glomerular Filtration Rate (eGFR)

    Time frame · From treatment week 1 to weeks 13, 25, 53, 65, 77, 101, 125, 149 and 173

    Registry description

    Change from baseline in eGFR, assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin C equation using serum concentrations of creatinine and cystatin C

  7. PLD Impact (PLD-I) Score

    Time frame · From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173

    Registry description

    Change from baseline in the PLD-I measure score

  8. Clinical Global Impression of Severity (CGI-S) Score

    Time frame · From treatment week 1 to weeks 13, 21, 25, 53, 77, 101, 125, 149 and 173

    Registry description

    Change from baseline in the CGI-S score

  9. Patient Global Impression of Severity (PGI-S) Score

    Time frame · From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173

    Registry description

    Change from baseline in the PGI-S score

  10. Patient Global Impression of Change (PGI-C) Score

    Time frame · At treatment weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173

    Registry description

    Change from baseline in the PGI-C score

  11. Short Form-36 (SF-36) Score

    Time frame · From treatment week 1 to weeks 25, 53, 77, 101, 125, 149 and 173

    Registry description

    Change from baseline in the SF-36 score

  12. Polycystic Liver Disease Questionnaire (PLD-Q)

    Time frame · From treatment week 1 to weeks 25, 53, 77, 101, 125, 149 and 173

    Registry description

    Change from baseline in the PLD-Q score

  13. Adverse Events (AEs)

    Time frame · From screening to the safety follow-up, assessed up to approximately 47 months.

    Registry description

    Incidence of AEs

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· From screening until treatment week 53

Height-adjusted Total Liver Volume (htTLV)

GroupValue (percentage)
CAM2029-0.7
Placebo3.9
Secondary and other outcome results(7)
Secondary outcome· From screening to Week 53

PLD Symptom (PLD-S) Score

GroupValue
Secondary outcome· From screening until treatment weeks 13, 25, 77, 125 and 173

htTLV

GroupValue
Secondary outcome· From screening to weeks 13, 21, 25, 39, 77, 101, 125, 149 and 173

PLD-S

GroupValue
Secondary outcome· From screening until treatment weeks 13, 25, 53, 77, 125 and 173

Height-adjusted Total Kidney Volume (htTKV)

GroupValue
Secondary outcome· From screening to treatment weeks 13, 25, 53, 77, 125 and 173

Total Liver Cyst Volume

GroupValue
Secondary outcome· From treatment week 1 to weeks 13, 25, 53, 65, 77, 101, 125, 149 and 173

Estimated Glomerular Filtration Rate (eGFR)

GroupValue
Secondary outcome· From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173

PLD Impact (PLD-I) Score

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
CAM2029 Once Weekly0.5 mL CAM2029 10 mg, subcutaneous (SC) injection, once weekly0 / 242 / 2424 / 24
CAM2029 Once Every 2 Weeks0.5 mL CAM2029 10 mg, SC injection,every 2 weeks and 0.5 mL placebo, SC injection, once every 2 weeks (alternating with CAM2029 dosing)1 / 233 / 2321 / 23
Placebo0.5 mL placebo, SC injection, once weekly0 / 235 / 2322 / 23

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedSt Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3. PMID 39356039

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female patient, ≥18 years at screening * Diagnosis of PLD (associated with ADPKD or isolated as in ADPLD) as defined by htTLV ≥1800 mL/m at screening * Presence of at least 1 of the following PLD-related symptoms within 2 weeks before screening: bloating, fullness in abdomen, lack of appetite, feeling full quickly after beginning to eat, acid reflux, nausea, rib cage pain or pressure, pain in side, abdominal pain, back pain, shortness of breath after physical exertion, limited in mobility, concern about abdomen getting larger, dissatisfied by the size of abdomen * Not a candidate for, or not willing to undergo, surgical intervention for hepatic cysts during the trial Exclusion Criteria: * Surgical intervention for PLD within 3 months before screening * Treatment with a somatostatin analogue (SSA) within 3 months before screening * Non-responsive to previous treatment of PLD with an SSA as per the Investigator's assessment * Systematic cholelithiasis within 3 months before screening or previous medical history of cholelithiasis induced by SSAs unless treated with cholecystectomy * Presence of extrahepatic cysts that, in the Investigator's opinion, may prevent the patient from safely participating in the trial * Severe kidney disease, as defined by eGFR \<30 mL/min/1.73\^m2 * Severe liver disease defined as liver cirrhosis of Child-Pugh class C * Any other current or prior medical condition that may interfere with the conduct of the trial or the evaluation of its results in the opinion of the Investigator

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