ClinicalTrials.gg
CompletedNCT01670110SOM230Updated May 1, 2020Results posted

Pasireotide LAR in Severe Polycystic Liver Disease

A Phase 2 interventional study of Pasireotide LAR and Placebo in Somatostatin Analogs, Polycystic Liver Disease and Autosomal Dominant Polycystic Kidney Disease, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-05-01.

Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 15 studies in Polycystic Kidney, Autosomal Dominant by Mayo Clinic — 4 open to participants now, 7 under way, none of them phase 3. Polycystic Kidney, Autosomal Dominant · Mayo Clinic.

Started
2012
the only one that year
Phase 2
2 of 15
none open now
Registered
4th of 15
by date

Among the 15 studies in Polycystic Kidney, Autosomal Dominant by Mayo Clinic, this one is the only one that started in 2012, is one of 2 in phase 2, and was the 4th registered.

By phase

15 studies; the count open now beside each. This study's row is marked.

Observational9 · 3 open
No phase3 · 1 open
Phase 2this study2 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2007; this study’s year is marked. 1 started in 2012.

Size and results

Median enrollment 39 across the 6 interventional studies, 60 across the 9 observational. Of the 8 that completed or were terminated, 3 (38%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 15 studies in Polycystic Kidney, Autosomal Dominant by Mayo Clinic, or all of them as a file.
02

Study summary

The purpose of this study is to compare SOM230 treatment to placebo. The investigators will also assess the efficacy and safety of SOM230 in reducing total liver volume and improving quality of life.

Read the detailed description

Pasireotide (SOM230) is a novel multi-receptor-targeted analog that has high affinity for four of the five SST receptor subtypes (SSTr1, SSTr2, SSTr3 and SSTr5); it has a 40-fold higher affinity and 158-fold higher functional activity for the SST5 receptor than octreotide. Because of its broad receptor binding profile, pasireotide may be more potent in Polycystic Liver Disease (PLD) than octreotide. In this randomized double blind placebo controlled trial the investigators will compare SOM230 treatment to placebo for 12 months in patients with PLD. The primary endpoints will be assessed at 12 months and patients receiving placebo then crossed over to SOM230, permitting all participants to receive SOM230 for the subsequent two years. Magnetic resonance imaging (MRI) will be used to assess liver volume - the primary endpoint, which will be assessed at baseline, end of years 1 and 3. This study will assess the efficacy and safety of SOM230 in reducing total liver volume and improving quality of life over 12 months. (The investigators will not be assessing efficacy at 24 months.) The therapy way be effective in PLD but also may prove to be effective for many more patients with Polycystic Kidney Disease (PKD) which will be evaluated using eGFR and kidney volume using MRI.

The investigators plan to add other sub-sites in other locations.

03

Conditions studied

  • Somatostatin Analogs
  • Polycystic Liver Disease
  • Autosomal Dominant Polycystic Kidney Disease
  • Autosomal Dominant Polycystic Liver Disease

Keywords

  • Polycystic Liver Disease
  • Autosomal dominant polycystic kidney disease
  • Autosomal dominant polycystic liver disease
  • Somatostatin analogs
  • Pasireotide LAR
  • SOM230
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female Age ≥ 18 years.
  • Diagnosis of PLD associated with ADPKD (meeting the Modified Ravine's criteria) or isolated ADPLD (defined by the criteria described by Reynolds et al)
  • Severe PLD defined as a liver volume >4000mL or symptomatic disease due to mass effects from hepatic cysts (must be able to undergo MRI or CT scan to determine this).
  • Not a candidate for or declining surgical intervention.
  • Capable of providing .
  • ≥ 12 weeks
  • Patients with a known history of impaired fasting blood glucose (glucose >100 and \<126) may be included at the discretion of the PI. These patients should be monitored closely throughout the trial and antihyperglycemic treatment adjusted as necessary. Patients that are deemed non eligible due to elevated glucose can be re-screened after adequate medical treatment.
  • Adequate end organ function as defined by:
  • Adequate bone marrow function:

    • WBC ≥ 2.5 x 109/L
    • (ANC) ≥ 1.5 x 109/L
    • ≥ 100 x 109/L
    • ≥ 9 g/dL
  • No evidence of significant liver disease:

    • Serum ≤1.5 x
    • \< 1.3
    • and AST ≤ 2 x ULN
  • Estimated (eGFR) >30 ml/min/m2
  • Serum amylase and lipase ≤ 1.5 x ULN
  • Alkaline phosphatase ≤ 2.5 x ULN
  • Written informed consent obtained prior to any screening procedures
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures

Exclusion criteria

Exclusion Criteria:

  • Patients will be considered ineligible for this study if they meet any of the following criteria:
  • Patients with a known to SST analogs or any component of the pasireotide LAR or SQ formulations.
  • Patients with known malabsorption syndrome, short bowel or chologenic diarrhea not controlled by specific therapeutic means.
  • Patients with abnormal coagulation (PT or a elevated by 30% above normal limits).
  • Patients on continuous anticoagulation therapy. Patients who were on anticoagulant therapy must complete a of at least 10 days and have confirmed normal coagulation parameters before study inclusion.
  • Patients with symptomatic cholelithiasis.
  • Patients who are not biochemically euthyroid.
  • Patients with known history of hypothyroidism are eligible if they are on adequate and stable re-placement thyroid hormone therapy for at least 3 months.
  • Serum magnesium ≥
  • -related exclusion criteria:
  • QTcF at screening > 470 msec
  • Patients with a history of syncope or family history of idiopathic sudden death
  • Patients who have sustained or cardiac arrhythmias
  • Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block
  • Patients with concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), , cirrhosis, uncontrolled hypothyroidism or cardiac failure
  • Family history of long QT syndrome
  • Concomitant medications known to prolong the QT interval.
  • Potassium \< or = to 3.5
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
  • Patients who have Uncontrolled diabetes as defined by >8%* despite adequate therapy
  • Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunodeficiency, including a positive HIV test result (ELISA and Western blot). An HIV test will not be required; however, previous medical history will be reviewed.
  • Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment.
  • Liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis or chronic persistent hepatitis.
  • Baseline or AST >3x ULN
  • Patients with life-threatening and ischemic disorders.
  • Uncontrolled hypertension
  • Patients who have a history of a primary , with the exception of locally excised non-melanoma skin cancer and carcinoma in situ of uterine cervix. (Patients who have had no evidence of disease from primary cancer for 3 or more years are allowed to participate in the study.)
  • History of pancreatitis
  • Patients with a known history of or C
  • Presence of Hepatitis B surface antigen (HbsAg)
  • Presence of antibody (anti-HCV)
  • Patients with a history of, or current, alcohol misuse/abuse within the past 12 months
  • Known gallbladder or bile duct disease, acute or chronic pancreatitis
  • Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator or the Sponsor's Medical Monitor
  • Use of an drug within 1 month prior to dosing
  • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study
Terms in these criteria, in plain language(21)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    Pasireotide LAR (SOM230)

    Active Pasireotide LAR

    Drug: Pasireotide LAR

  • Placebo comparator
    placebo injection

    Drug: Placebo

Interventions

  • Injectible, 60mg per month

  • DrugPlacebo

    To be injected once per month

06

What researchers measure

Primary outcomes

  1. Change in Liver Volume

    Percent change was calculated for liver volumes using the equation=\[(12 month value-baseline value)/baseline value\]\*100\*12/12 month

    Time frame: baseline , 12 month

  2. Change in Kidney Volume

    Percent change was calculated for kidney volumes using the equation=\[(12 month value-baseline value)/baseline value\]\*100\*12/12 month

    Time frame: baseline to 12 months

Secondary outcomes

  1. Percentage Change in Estimated Glomerular Filtration Rate (eGFR)

    eGFR was measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. This value at baseline and 12 months was used to calculate the percentage change by \[12 month value-baseline value)/baseline value\]\*100

    Time frame: Baseline, 12 months

  2. Percentage Change in Serum Creatinine

    Serum creatinine level at baseline and 12 months was used to calculate the percentage change by \[12 month value-baseline value)/baseline value\]\*100

    Time frame: Baseline, 12 months

  3. Percent Change in Blood Glucose

    Blood glucose (mg/dLb) level at baseline and 12 months was used to calculate the percentage change by \[12 month value-baseline value)/baseline value\]\*100

    Time frame: Baseline, 12 months

  4. Percentage Change in Hemoglobin A1C

    Hemoglobin A1C level at baseline and 12 months was used to calculate the percentage change by \[12 month value-baseline value)/baseline value\]\*100

    Time frame: Baseline, 12 months

  5. Percentage Change in Heart Rate

    Heart rate, measured in beats per minute (BPM), at baseline and 12 months was used to calculate the percentage change by \[12 month value-baseline value)/baseline value\]\*100

    Time frame: Baseline, 12 months

  6. Change in Quality of Life

    Measured using the SF-36 health survey, which consist of eight subscales each scored on a range of 0 to 100 (0=worst imaginable, 100=best imaginable). Change calculated from baseline = 12 month value-baseline value

    Time frame: Baseline, 12 months

07

Results

Posted Mar 2, 2020

Participant flow

Participant flow — Overall Study
MilestonePasireotide LAR (SOM230)Placebo Injection
Started3315
Completed2912
Not completed43

Outcome measures

PrimaryChange in Liver Volume

Percent change was calculated for liver volumes using the equation=\[(12 month value-baseline value)/baseline value\]\*100\*12/12 month

Time frame:
baseline , 12 month
Reported as:
Mean · percentage of change
Change in Liver Volume
percentage of changePasireotide LAR (SOM230)Placebo Injection
Change in Liver Volume-3.36 ± 7.336.29 ± 6.97
Statistical analysis
  • Pasireotide LAR (SOM230) vs Placebo Injection · ANCOVA · p = 0.001
PrimaryChange in Kidney Volume

Percent change was calculated for kidney volumes using the equation=\[(12 month value-baseline value)/baseline value\]\*100\*12/12 month

Time frame:
baseline to 12 months
Reported as:
Mean · percentage of change
Change in Kidney Volume
percentage of changePasireotide LAR (SOM230)Placebo Injection
Change in Kidney Volume-1.37 ± 3.523.85 ± 4.49
Statistical analysis
  • Pasireotide LAR (SOM230) vs Placebo Injection · ANCOVA · p = 0.003
SecondaryPercentage Change in Estimated Glomerular Filtration Rate (eGFR)

eGFR was measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. This value at baseline and 12 months was used to calculate the percentage change by \[12 month value-baseline value)/baseline value\]\*100

Time frame:
Baseline, 12 months
Reported as:
Mean · percentage of change
Percentage Change in Estimated Glomerular Filtration Rate (eGFR)
percentage of changePasireotide LAR (SOM230)Placebo Injection
Percentage Change in Estimated Glomerular Filtration Rate (eGFR)-0.3 ± 14-2.2 ± 17.7
Statistical analysis
  • Pasireotide LAR (SOM230) vs Placebo Injection · t-test, 2 sided · p = 0.79
SecondaryPercentage Change in Serum Creatinine

Serum creatinine level at baseline and 12 months was used to calculate the percentage change by \[12 month value-baseline value)/baseline value\]\*100

Time frame:
Baseline, 12 months
Reported as:
Mean · percentage of change
Percentage Change in Serum Creatinine
percentage of changePasireotide LAR (SOM230)Placebo Injection
Percentage Change in Serum Creatinine1.8 ± 123.4 ± 15.6
Statistical analysis
  • Pasireotide LAR (SOM230) vs Placebo Injection · t-test, 2 sided · p = 0.79
SecondaryPercent Change in Blood Glucose

Blood glucose (mg/dLb) level at baseline and 12 months was used to calculate the percentage change by \[12 month value-baseline value)/baseline value\]\*100

Time frame:
Baseline, 12 months
Reported as:
Mean · percentage of change
Percent Change in Blood Glucose
percentage of changePasireotide LAR (SOM230)Placebo Injection
Percent Change in Blood Glucose39 ± 302.2 ± 15.2
Statistical analysis
  • Pasireotide LAR (SOM230) vs Placebo Injection · t-test, 2 sided · p = 0.001
SecondaryPercentage Change in Hemoglobin A1C

Hemoglobin A1C level at baseline and 12 months was used to calculate the percentage change by \[12 month value-baseline value)/baseline value\]\*100

Time frame:
Baseline, 12 months
Reported as:
Mean · percentage of change
Percentage Change in Hemoglobin A1C
percentage of changePasireotide LAR (SOM230)Placebo Injection
Percentage Change in Hemoglobin A1C18 ± 111.6 ± 3.3
Statistical analysis
  • Pasireotide LAR (SOM230) vs Placebo Injection · t-test, 2 sided · p = 0.001
SecondaryPercentage Change in Heart Rate

Heart rate, measured in beats per minute (BPM), at baseline and 12 months was used to calculate the percentage change by \[12 month value-baseline value)/baseline value\]\*100

Time frame:
Baseline, 12 months
Reported as:
Mean · percentage of change
Percentage Change in Heart Rate
percentage of changePasireotide LAR (SOM230)Placebo Injection
Percentage Change in Heart Rate-0.15 ± 0.2-0.1 ± 0.1
Statistical analysis
  • Pasireotide LAR (SOM230) vs Placebo Injection · t-test, 2 sided · p = 0.73
SecondaryChange in Quality of Life

Measured using the SF-36 health survey, which consist of eight subscales each scored on a range of 0 to 100 (0=worst imaginable, 100=best imaginable). Change calculated from baseline = 12 month value-baseline value

Time frame:
Baseline, 12 months
Reported as:
Mean · units on a scale
Change in Quality of Life
units on a scalePasireotide LAR (SOM230)Placebo Injection
Physical functioning4.7 ± 16-1 ± 8
Physical role7.9 ± 36-3 ± 38
Bodily pain5.5 ± 227 ± 12
General health-6.2 ± 142 ± 15
Vitality4.5 ± 14-2 ± 17
Social functioning0.0 ± 18-3 ± 8
Role emotional0.0 ± 2211 ± 5
Mental health1.5 ± 12-1.8 ± 11
Statistical analysis
  • Pasireotide LAR (SOM230) vs Placebo Injection · t-test, 2 sided · p = 0.31
  • Pasireotide LAR (SOM230) vs Placebo Injection · t-test, 2 sided · p = 0.48
  • Pasireotide LAR (SOM230) vs Placebo Injection · t-test, 2 sided · p = 0.89
  • Pasireotide LAR (SOM230) vs Placebo Injection · t-test, 2 sided · p = 0.18
  • Pasireotide LAR (SOM230) vs Placebo Injection · t-test, 2 sided · p = 0.28
  • Pasireotide LAR (SOM230) vs Placebo Injection · t-test, 2 sided · p = 0.66
  • Pasireotide LAR (SOM230) vs Placebo Injection · t-test, 2 sided · p = 0.43
  • Pasireotide LAR (SOM230) vs Placebo Injection · t-test, 2 sided · p = 0.51

Adverse events

Collected over Adverse Events were collected from baseline to 12 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pasireotide LAR (SOM230)0/33 (0%)4/33 (12.1%)33/33 (100%)
Placebo Injection1/15 (6.7%)1/15 (6.7%)15/15 (100%)
Most frequent serious events
Most frequent serious events
EventPasireotide LAR (SOM230)Placebo Injection
Abdominal hernia repairSurgical and medical procedures0/331/15
Ruptured liver cystHepatobiliary disorders1/330/15
Elevated alkaline phosphataseHepatobiliary disorders1/330/15
Prolonged QT>480msecCardiac disorders1/330/15
Right upper quadrant painGeneral disorders1/330/15
Abdominal painGastrointestinal disorders1/330/15
AscitesGeneral disorders1/330/15
Most frequent other events
Most frequent other events
EventPasireotide LAR (SOM230)Placebo Injection
HyperglycemiaMetabolism and nutrition disorders26/334/15
DiabetesEndocrine disorders19/321/15
DiarrheaGastrointestinal disorders17/338/15
FatigueGeneral disorders13/333/15
Pain abdomenGastrointestinal disorders11/331/15
DizzinessNervous system disorders10/333/15
BradycardiaCardiac disorders10/331/15
NauseaGastrointestinal disorders9/333/15
AlopeciaGeneral disorders9/330/15
HeadacheNervous system disorders5/333/15

Baseline characteristics

Age, Continuous
Age, Continuous(years)Pasireotide LAR (SOM230)Placebo InjectionTotal
Mean50.16 ± 8.6351.40 ± 7.9750.55 ± 8.37
Sex: Female, Male
Sex: Female, Male(Participants)Pasireotide LAR (SOM230)Placebo InjectionTotal
Female311243
Male235
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Pasireotide LAR (SOM230)Placebo InjectionTotal
White291544
African American101
Other303
Region of Enrollment
Region of Enrollment(participants)Pasireotide LAR (SOM230)Placebo InjectionTotal
United States331548
08

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
09

References and documents

Publications

  • Hogan MC, Chamberlin JA, Vaughan LE, Waits AL, Banks C, Leistikow K, Oftsie T, Madsen C, Edwards M, Glockner J, Kremers WK, Harris PC, LaRusso NF, Torres VE, Masyuk TV. Pansomatostatin Agonist Pasireotide Long-Acting Release for Patients with Autosomal Dominant Polycystic Kidney or Liver Disease with Severe Liver Involvement: A Randomized Clinical Trial. Clin J Am Soc Nephrol. 2020 Sep 7;15(9):1267-1278. doi: 10.2215/CJN.13661119. Epub 2020 Aug 25. PubMed 32843370 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2012 to primary completion in Sep 2018, 73 months.

Results were first posted in Mar 2020, 1 year 6 months after primary completion.

Of 17 phase 2 interventional studies under Polycystic Kidney, Autosomal Dominant, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's 73 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2012
First posted
Aug 21, 2012
StartActual
Aug 2012
Primary completionActual
Sep 2018
CompletionActual
Sep 2018
Results first posted
Mar 2, 2020
Last update
May 1, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01670110
Lead sponsor
Mayo Clinic
Responsible party
Marie Hogan (Assistant Professor of Medicine, Mayo Clinic) — Principal investigator
First posted
Aug 21, 2012
Start date
Aug 2012
Primary completion
Sep 2018
Completion
Sep 2018
Results posted
Mar 2, 2020
Last update
May 1, 2020

Study contacts

Marie C Hogan, MD PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Pasireotide

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