Study · Randomized controlled trial · n = 63 · 2019

6 results

Octreotide-LAR in later-stage autosomal dominant polycystic kidney disease (ALADIN 2): A randomized, double-blind, placebo-controlled, multicenter trial.

Perico N, Ruggenenti P, Perna A, Caroli A, Trillini M, Sironi S, Pisani A, Riccio E, Imbriaco M, Dugo M, Morana G, Granata A and 11 more

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Figuera M, Gaspari F, Carrara F, Carrara F, Rubis N, Villa A, Gamba S, Prandini S, Cortinovis M, Remuzzi A, Remuzzi G

PLoS medicine5 Apr 2019Cited by 61 (Europe PMC)

PMID30951521PMCIDPMC6450618DOI10.1371/journal.pmed.1002777PepBankPUB-30951521

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Summary

BackgroundAutosomal dominant polycystic kidney disease (ADPKD) is the most frequent genetically determined renal disease. In affected patients, renal function may progressively decline up to end-stage renal disease (ESRD), and approximately 10% of those with ESRD are affected by ADPKD. The somatostatin analog octreotide long-acting release (octreotide-LAR) slows renal function deterioration in patients in early stages of the disease. We evaluated the renoprotective effect of octreotide-LAR in ADPKD patients at high risk of ESRD because of later-stage ADPKD.Methods and findingsWe did an internally funded, parallel-group, double-blind, placebo-controlled phase III trial to assess octreotide-LAR in adults with ADPKD with glomerular filtration rate (GFR) 15-40 ml/min/1.73 m2. Participants were randomized to receive 2 intramuscular injections of 20 mg octreotide-LAR (n = 51) or 0.9% sodium chloride solution (placebo; n = 49) every 28 days for 3 years. Central randomization was 1:1 using a computerized list stratified by center and presence or absence of diabetes or proteinuria. Co-primary short- and long-term outcomes were 1-year total kidney volume (TKV) (computed tomography scan) growth and 3-year GFR (iohexol plasma clearance) decline. Analyses were by modified intention-to-treat. Patients were recruited from 4 Italian nephrology units between October 11, 2011, and March 20, 2014, and followed up to April 14, 2017. Baseline characteristics were similar between groups. Compared to placebo, octreotide-LAR reduced median (95% CI) TKV growth from baseline by 96.8 (10.8 to 182.7) ml at 1 year (p = 0.027) and 422.6 (150.3 to 695.0) ml at 3 years (p = 0.002). Reduction in the median (95% CI) rate of GFR decline (0.56 [-0.63 to 1.75] ml/min/1.73 m2 per year) was not significant (p = 0.295). TKV analyses were adjusted for age, sex, and baseline TKV. Over a median (IQR) 36 (24 to 37) months of follow-up, 9 patients on octreotide-LAR and 21 patients on placebo progressed to a doubling of serum creatinine or ESRD (composite endpoint) (hazard ratio [HR] [95% CI] adjusted for age, sex, baseline serum creatinine, and baseline TKV: 0.307 [0.127 to 0.742], p = 0.009). One composite endpoint was prevented for every 4 treated patients. Among 63 patients with chronic kidney disease (CKD) stage 4, 3 on octreotide-LAR and 8 on placebo progressed to ESRD (adjusted HR [95% CI]: 0.121 [0.017 to 0.866], p = 0.036). Three patients on placebo had a serious renal cyst rupture/infection and 1 patient had a serious urinary tract infection/obstruction, versus 1 patient on octreotide-LAR with a serious renal cyst infection. The main study limitation was the small sample size.ConclusionsIn this study we observed that in later-stage ADPKD, octreotide-LAR slowed kidney growth and delayed progression to ESRD, in particular in CKD stage 4.Trial registrationClinicalTrials.gov NCT01377246; EudraCT: 2011-000138-12.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with later-stage ADPKD, octreotide-LAR reduced TKV growth by 96.8 ml versus placebo at 1 year (95% CI 10.8-182.7; p = 0.027).
In plain wordsIn adults with later-stage ADPKD, octreotide-LAR reduced kidney growth more than placebo at 1 year.
Peptide
Octreotide
Outcome
DecreaseTKV growth at 1 year
Study
n: not reported in source
Comparator
placebo
Analysis
Primary
Outcome group
Kidney function · Kidney and urinary
Studied dose
2 injections of 20 mg every 28 days · intramuscularAs given in this study (human).
Measurements
TKV growth difference
96.8 ml
1 year
95% CI
10.8 to 182.7 ml
1 year
Source sentences
Summary
Compared to placebo, octreotide-LAR reduced median (95% CI) TKV growth from baseline by 96.8 (10.8 to 182.7) ml at 1 year (p = 0.027) and 422.6 (150.3 to 695.0) ml at 3 years (p = 0.002).
2 context sentences(design, population, supporting numbers)
Summary · context
We did an internally funded, parallel-group, double-blind, placebo-controlled phase III trial to assess octreotide-LAR in adults with ADPKD with glomerular filtration rate (GFR) 15-40 ml/min/1.73 m2.
Summary · context
Participants were randomized to receive 2 intramuscular injections of 20 mg octreotide-LAR (n = 51) or 0.9% sodium chloride solution (placebo; n = 49) every 28 days for 3 years.
Show in the study text Report a problemFND-3095152101
02HumanRandomized controlled trialEfficacy outcome
In adults with later-stage ADPKD, octreotide-LAR reduced GFR decline rate by 0.56 ml/min/1.73 m2 per year versus placebo, without significance (p = 0.295).
In plain wordsIn adults with later-stage ADPKD, GFR declined less with octreotide-LAR than placebo, but the difference was not significant.
Peptide
Octreotide
Outcome
DecreaseGFR decline rate
Study
n: not reported in source
Comparator
placebo
Analysis
Primary
Outcome group
Kidney function · Kidney and urinary
Studied dose
2 injections of 20 mg every 28 days · intramuscular · 3 yearsAs given in this study (human).
Measurements
GFR decline rate reduction
0.56 ml/min/1.73 m2 per year
reported result
95% CI
−0.63 to 1.75 ml/min/1.73 m2 per year
reported result
Source sentences
Summary
Reduction in the median (95% CI) rate of GFR decline (0.56 [-0.63 to 1.75] ml/min/1.73 m2 per year) was not significant (p = 0.295).
2 context sentences(design, population, supporting numbers)
Summary · context
We did an internally funded, parallel-group, double-blind, placebo-controlled phase III trial to assess octreotide-LAR in adults with ADPKD with glomerular filtration rate (GFR) 15-40 ml/min/1.73 m2.
Summary · context
Participants were randomized to receive 2 intramuscular injections of 20 mg octreotide-LAR (n = 51) or 0.9% sodium chloride solution (placebo; n = 49) every 28 days for 3 years.
Show in the study text Report a problemFND-3095152103
03HumanRandomized controlled trialEfficacy outcome
In CKD stage 4, ESRD occurred in 3 octreotide-LAR versus 8 placebo patients (adjusted HR 0.121; 95% CI 0.017-0.866; p = 0.036).
In plain wordsIn patients with CKD stage 4, kidney failure occurred less often with octreotide-LAR than placebo.
Peptide
Octreotide
Outcome
DecreaseESRD in CKD stage 4
Study
n = 63
Comparator
placebo
Outcome group
Kidney function · Kidney and urinary
Studied dose
2 injections of 20 mg every 28 days · intramuscular · 3 yearsAs given in this study (human).
Measurements
ESRD
3 patients
octreotide-LAR
ESRD
8 patients
placebo
Adjusted HR
0.121
reported comparison
95% CI
0.017 to 0.866
reported comparison
Source sentences
Summary
Among 63 patients with chronic kidney disease (CKD) stage 4, 3 on octreotide-LAR and 8 on placebo progressed to ESRD (adjusted HR [95% CI]: 0.121 [0.017 to 0.866], p = 0.036).
2 context sentences(design, population, supporting numbers)
Summary · context
We did an internally funded, parallel-group, double-blind, placebo-controlled phase III trial to assess octreotide-LAR in adults with ADPKD with glomerular filtration rate (GFR) 15-40 ml/min/1.73 m2.
Summary · context
Participants were randomized to receive 2 intramuscular injections of 20 mg octreotide-LAR (n = 51) or 0.9% sodium chloride solution (placebo; n = 49) every 28 days for 3 years.
Show in the study text Report a problemFND-3095152105
04HumanRandomized controlled trialEfficacy outcome
In adults with later-stage ADPKD, octreotide-LAR reduced TKV growth by 422.6 ml versus placebo at 3 years (95% CI 150.3-695.0; p = 0.002).
In plain wordsIn adults with later-stage ADPKD, octreotide-LAR reduced kidney growth more than placebo at 3 years.
Peptide
Octreotide
Outcome
DecreaseTKV growth at 3 years
Study
n: not reported in source
Comparator
placebo
Outcome group
Kidney function · Kidney and urinary
Studied dose
2 injections of 20 mg every 28 days · intramuscular · 3 yearsAs given in this study (human).
Measurements
TKV growth difference
422.6 ml
3 years
95% CI
150.3 to 695 ml
3 years
Source sentences
Summary
Compared to placebo, octreotide-LAR reduced median (95% CI) TKV growth from baseline by 96.8 (10.8 to 182.7) ml at 1 year (p = 0.027) and 422.6 (150.3 to 695.0) ml at 3 years (p = 0.002).
2 context sentences(design, population, supporting numbers)
Summary · context
We did an internally funded, parallel-group, double-blind, placebo-controlled phase III trial to assess octreotide-LAR in adults with ADPKD with glomerular filtration rate (GFR) 15-40 ml/min/1.73 m2.
Summary · context
Participants were randomized to receive 2 intramuscular injections of 20 mg octreotide-LAR (n = 51) or 0.9% sodium chloride solution (placebo; n = 49) every 28 days for 3 years.
Show in the study text Report a problemFND-3095152102
05HumanRandomized controlled trialEfficacy outcome
In adults with later-stage ADPKD, creatinine doubling or ESRD occurred in 9 octreotide-LAR versus 21 placebo patients (adjusted HR 0.307; p = 0.009).
In plain wordsIn adults with later-stage ADPKD, creatinine doubling or kidney failure occurred less often with octreotide-LAR than placebo.
Peptide
Octreotide
Outcome
DecreaseCreatinine doubling or ESRD
Study
n: not reported in source
Comparator
placebo
Outcome group
Kidney function · Kidney and urinary
Studied dose
2 injections of 20 mg every 28 days · intramuscular · 3 yearsAs given in this study (human).
Measurements
Events
9 patients
octreotide-LAR
Events
21 patients
placebo
Adjusted HR
0.307
reported comparison
95% CI
0.127 to 0.742
reported comparison
Number needed to treat
4 patients
reported result
Source sentences
Summary
Over a median (IQR) 36 (24 to 37) months of follow-up, 9 patients on octreotide-LAR and 21 patients on placebo progressed to a doubling of serum creatinine or ESRD (composite endpoint)
4 context sentences(design, population, supporting numbers)
Summary · context
(hazard ratio [HR] [95% CI] adjusted for age, sex, baseline serum creatinine, and baseline TKV: 0.307 [0.127 to 0.742], p = 0.009).
Summary · context
One composite endpoint was prevented for every 4 treated patients.
Summary · context
We did an internally funded, parallel-group, double-blind, placebo-controlled phase III trial to assess octreotide-LAR in adults with ADPKD with glomerular filtration rate (GFR) 15-40 ml/min/1.73 m2.
Summary · context
Participants were randomized to receive 2 intramuscular injections of 20 mg octreotide-LAR (n = 51) or 0.9% sodium chloride solution (placebo; n = 49) every 28 days for 3 years.
Show in the study text Report a problemFND-3095152104
06HumanNon-randomized trialSafety outcome
In adults with later-stage ADPKD, one octreotide-LAR patient had a serious renal cyst infection.
In plain wordsIn adults with later-stage ADPKD, one octreotide-LAR patient had a serious kidney cyst infection.
Peptide
Octreotide
Outcome
Not applicableSerious renal cyst infection
Study
n: not reported in source
Outcome group
Adverse events · Kidney and urinary
Studied dose
2 injections of 20 mg every 28 days · intramuscular · 3 yearsAs given in this study (human).
Measurements
Serious renal cyst infection
1 patient
octreotide-LAR
Source sentences
Summary
Three patients on placebo had a serious renal cyst rupture/infection and 1 patient had a serious urinary tract infection/obstruction, versus 1 patient on octreotide-LAR with a serious renal cyst infection.
2 context sentences(design, population, supporting numbers)
Summary · context
We did an internally funded, parallel-group, double-blind, placebo-controlled phase III trial to assess octreotide-LAR in adults with ADPKD with glomerular filtration rate (GFR) 15-40 ml/min/1.73 m2.
Summary · context
Participants were randomized to receive 2 intramuscular injections of 20 mg octreotide-LAR (n = 51) or 0.9% sodium chloride solution (placebo; n = 49) every 28 days for 3 years.
Show in the study text Report a problemFND-3095152106

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 1 ongoing · 1 completed · source ClinicalTrials.gov (opens in a new tab)

Active, not recruitingPhase not statedNCT06193616

Outcome of ADPKD With Octreotide LAR

Mario Negri Institute for Pharmacological Researchn = 7012 Feb 2024 to est. Dec 2025

Autosomal Dominant Polycystic Kidney

Trial page ClinicalTrials.govUpdated 5 Sept 2025

CompletedPhase 3NCT01377246

Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal Insufficiency

Mario Negri Institute for Pharmacological Researchn = 100May 2011 to 18 Oct 2017

Autosomal Dominant Polycystic Kidney Disease

Trial page ClinicalTrials.govUpdated 10 Jan 2018

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

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