A three-year randomized, double-blind, placebo-controlled study of lanreotide in stage 2/3 autosomal dominant polycystic kidney disease.

Joly D, Ursino M, Bienaimé F, El Karoui K, Karras A, Thervet E, Boffa JJ, Galichon P, Luque Y, Michel PA, Cartery C, Vrtovsnik F and 11 more

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Daugas E, Peraldi MN, Colas S, Semeraro M, Treluyer JM, Meyzer C, Hummel A, Fouchard M, Nguyen-Khoa T, Knebelmann B, Alberti C

Kidney international19 Jun 2026

PMID42320793DOI10.1016/j.kint.2026.05.018PepBankPUB-42320793

Publisher page PubMedAsk about this study

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Summary

IntroductionSomatostatin analogues reduce liver and kidney cyst volume in autosomal dominant polycystic kidney disease (ADPKD), but randomized trials have not demonstrated a consistent benefit on kidney function decline. We tested whether the analogue lanreotide slows glomerular filtration rate (GFR) decline over three years in adults with ADPKD stages 2/3.MethodsIn this randomized, double-blind, placebo-controlled trial, we enrolled adults with ADPKD and measured GFR (mGFR) 30-89 ml/min/1.73 m². Patients were randomized to receive monthly injections of lanreotide 120 mg or 0.9% sodium chloride placebo for three years. The primary endpoint was mGFR slope (iohexol clearance) assessed at baseline, weeks 72 and 144 and analyzed with a linear mixed-effects model (LMM). Secondary endpoints included annual estimated GFR decline (creatinine-based, assessed at 11 scheduled visits), kidney events, quality of life, and safety. Due to slow enrollment, recruitment stopped after 144 of 180 planned participants. All randomized participants were included in the analysis (intention-to-treat).ResultsThe primary endpoint was not met: the model-derived annualized between-arm difference in mGFR trajectory was -0.3 ml/min/1.73 m² per year (95% confidence interval -3.4 to 2.8). The time × lanreotide coefficient from the pre-specified creatinine-eGFR LMM was significant +1.2 ml/min/1.73 m² per year (0.27 to 2.15); however, this signal was not replicated by cystatin C-eGFR nor urinary creatinine clearance, consistent with a non-GFR effect on creatinine physiology. Rates of kidney events and quality-of-life scores were similar between arms. Gastrointestinal adverse events were more frequent with lanreotide. Hypoglycemia occurred in 11.1% of lanreotide-treated versus 1.4% of placebo-treated participants.ConclusionsLanreotide did not slow mGFR decline in adults with stage 2/3 ADPKD. The creatinine-eGFR signal is exploratory, not supported by muscle-mass-independent markers, and should be interpreted in the context of a negative primary endpoint. An unexpected hypoglycemia signal warrants proactive monitoring when considering lanreotide in this population.Trial registrationRegistered at ClinicalTrials.gov with study number NCT02127437.

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

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with stage 2/3 ADPKD, lanreotide versus placebo had an annualized mGFR trajectory difference of -0.3 ml/min/1.73 m²/year (95% CI -3.4 to 2.8).
In plain wordsIn adults with ADPKD, lanreotide did not improve measured kidney filtration versus placebo.
Peptide
Lanreotide
Outcome
No significant changeMeasured GFR trajectory
Study
n = 144
Comparator
placebo
Analysis
Primary
Outcome group
Kidney function · Kidney and urinary
Studied dose
120 mg monthly · injection · three yearsAs given in this study (human).
Measurements
Between-arm difference in mGFR trajectory
−0.3 ml/min/1.73 m2 per year
lanreotide versus placebo, model-derived annualized
95% CI of mGFR trajectory difference
−3.4 to 2.8 ml/min/1.73 m2 per year
lanreotide versus placebo
Source sentences
Summary
The primary endpoint was not met: the model-derived annualized between-arm difference in mGFR trajectory was -0.3 ml/min/1.73 m² per year (95% confidence interval -3.4 to 2.8).
3 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, double-blind, placebo-controlled trial, we enrolled adults with ADPKD and measured GFR (mGFR) 30-89 ml/min/1.73 m².
Summary · context
Patients were randomized to receive monthly injections of lanreotide 120 mg or 0.9% sodium chloride placebo for three years.
Summary · context
All randomized participants were included in the analysis (intention-to-treat).
Show in the study text Report a problemFND-4232079301
02HumanRandomized controlled trialEfficacy outcome
In adults with ADPKD, kidney event rates were similar with lanreotide and placebo.
In plain wordsIn adults with ADPKD, kidney event rates were similar with lanreotide and placebo.
Peptide
Lanreotide
Outcome
Direction not reportedKidney events
Study
n = 144
Comparator
placebo
Analysis
Secondary
Outcome group
Kidney function · Kidney and urinary
Studied dose
120 mg monthly · injection · three yearsAs given in this study (human).
Source sentences
Summary
Rates of kidney events and quality-of-life scores were similar between arms.
3 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, double-blind, placebo-controlled trial, we enrolled adults with ADPKD and measured GFR (mGFR) 30-89 ml/min/1.73 m².
Summary · context
Patients were randomized to receive monthly injections of lanreotide 120 mg or 0.9% sodium chloride placebo for three years.
Summary · context
All randomized participants were included in the analysis (intention-to-treat).
Show in the study text Report a problemFND-4232079305
03HumanRandomized controlled trialEfficacy outcome
In adults with ADPKD, quality-of-life scores were similar with lanreotide and placebo.
In plain wordsIn adults with ADPKD, quality-of-life scores were similar with lanreotide and placebo.
Peptide
Lanreotide
Outcome
Direction not reportedQuality of life
Study
n = 144
Comparator
placebo
Analysis
Secondary
Outcome group
Quality of life · Whole body
Studied dose
120 mg monthly · injection · three yearsAs given in this study (human).
Source sentences
Summary
Rates of kidney events and quality-of-life scores were similar between arms.
3 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, double-blind, placebo-controlled trial, we enrolled adults with ADPKD and measured GFR (mGFR) 30-89 ml/min/1.73 m².
Summary · context
Patients were randomized to receive monthly injections of lanreotide 120 mg or 0.9% sodium chloride placebo for three years.
Summary · context
All randomized participants were included in the analysis (intention-to-treat).
Show in the study text Report a problemFND-4232079306
04HumanRandomized controlled trialSafety outcome
In adults with ADPKD, gastrointestinal adverse events were more frequent with lanreotide than placebo.
In plain wordsIn adults with ADPKD, digestive adverse events were more frequent with lanreotide than placebo.
Peptide
Lanreotide
Outcome
IncreaseGastrointestinal adverse events
Study
n = 144
Comparator
placebo
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
120 mg monthly · injection · three yearsAs given in this study (human).
Source sentences
Summary
Gastrointestinal adverse events were more frequent with lanreotide.
3 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, double-blind, placebo-controlled trial, we enrolled adults with ADPKD and measured GFR (mGFR) 30-89 ml/min/1.73 m².
Summary · context
Patients were randomized to receive monthly injections of lanreotide 120 mg or 0.9% sodium chloride placebo for three years.
Summary · context
All randomized participants were included in the analysis (intention-to-treat).
Show in the study text Report a problemFND-4232079307
05HumanRandomized controlled trialSafety outcome
In adults with ADPKD, hypoglycemia occurred in 11.1% with lanreotide versus 1.4% with placebo.
In plain wordsIn adults with ADPKD, low blood sugar occurred in 11.1% with lanreotide versus 1.4% with placebo.
Peptide
Lanreotide
Outcome
IncreaseHypoglycemia
Study
n = 144
Comparator
placebo
Analysis
Secondary
Outcome group
Adverse events · Metabolic and weight
Studied dose
120 mg monthly · injection · three yearsAs given in this study (human).
Measurements
Hypoglycemia
11.1%
lanreotide-treated participants
Hypoglycemia
1.4%
placebo-treated participants
Source sentences
Summary
Hypoglycemia occurred in 11.1% of lanreotide-treated versus 1.4% of placebo-treated participants.
3 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, double-blind, placebo-controlled trial, we enrolled adults with ADPKD and measured GFR (mGFR) 30-89 ml/min/1.73 m².
Summary · context
Patients were randomized to receive monthly injections of lanreotide 120 mg or 0.9% sodium chloride placebo for three years.
Summary · context
All randomized participants were included in the analysis (intention-to-treat).
Show in the study text Report a problemFND-4232079308
06HumanRandomized controlled trialEfficacy outcome
In adults with stage 2/3 ADPKD, the time x lanreotide coefficient from the pre-specified creatinine-eGFR model was significant at +1.2 ml/min/1.73 m² per year (0.27 to 2.15); the authors call this signal exploratory and not supported by muscle-mass-independent markers.
In plain wordsIn adults with ADPKD, lanreotide was linked to a rise in the creatinine-based filtration estimate versus placebo, but other filtration measures did not confirm it.
Peptide
Lanreotide
Outcome
IncreaseCreatinine-eGFR trajectory
Study
n = 144
Comparator
placebo
Analysis
Exploratory
Outcome group
Kidney function · Kidney and urinary
Studied dose
120 mg monthly · injection · three yearsAs given in this study (human).
Measurements
Time x lanreotide coefficient, creatinine-eGFR
1.2 ml/min/1.73 m2 per year
pre-specified creatinine-eGFR LMM
Coefficient range, creatinine-eGFR
0.27 to 2.15 ml/min/1.73 m2 per year
interval as written
Source sentences
Summary
The time × lanreotide coefficient from the pre-specified creatinine-eGFR LMM was significant +1.2 ml/min/1.73 m² per year (0.27 to 2.15);
4 context sentences(design, population, supporting numbers)
Summary · context
The creatinine-eGFR signal is exploratory, not supported by muscle-mass-independent markers, and should be interpreted in the context of a negative primary endpoint.
Summary · context
In this randomized, double-blind, placebo-controlled trial, we enrolled adults with ADPKD and measured GFR (mGFR) 30-89 ml/min/1.73 m².
Summary · context
Patients were randomized to receive monthly injections of lanreotide 120 mg or 0.9% sodium chloride placebo for three years.
Summary · context
All randomized participants were included in the analysis (intention-to-treat).
Show in the study text Report a problemFND-4232079302
07HumanRandomized controlled trialEfficacy outcome
In adults with ADPKD, cystatin C-eGFR did not replicate the creatinine-eGFR signal with lanreotide.
In plain wordsIn adults with ADPKD, cystatin C-based filtration did not confirm the creatinine-based signal with lanreotide versus placebo.
Peptide
Lanreotide
Outcome
Direction not reportedCystatin C-eGFR signal
Study
n = 144
Comparator
placebo
Outcome group
Kidney function · Kidney and urinary
Studied dose
120 mg monthly · injection · three yearsAs given in this study (human).
Source sentences
Summary
however, this signal was not replicated by cystatin C-eGFR nor urinary creatinine clearance, consistent with a non-GFR effect on creatinine physiology.
3 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, double-blind, placebo-controlled trial, we enrolled adults with ADPKD and measured GFR (mGFR) 30-89 ml/min/1.73 m².
Summary · context
Patients were randomized to receive monthly injections of lanreotide 120 mg or 0.9% sodium chloride placebo for three years.
Summary · context
All randomized participants were included in the analysis (intention-to-treat).
Show in the study text Report a problemFND-4232079303
08HumanRandomized controlled trialEfficacy outcome
In adults with ADPKD, urinary creatinine clearance did not replicate the creatinine-eGFR signal with lanreotide.
In plain wordsIn adults with ADPKD, urinary creatinine clearance did not confirm the creatinine-based signal with lanreotide versus placebo.
Peptide
Lanreotide
Outcome
Direction not reportedUrinary creatinine clearance signal
Study
n = 144
Comparator
placebo
Outcome group
Kidney function · Kidney and urinary
Studied dose
120 mg monthly · injection · three yearsAs given in this study (human).
Source sentences
Summary
however, this signal was not replicated by cystatin C-eGFR nor urinary creatinine clearance, consistent with a non-GFR effect on creatinine physiology.
3 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, double-blind, placebo-controlled trial, we enrolled adults with ADPKD and measured GFR (mGFR) 30-89 ml/min/1.73 m².
Summary · context
Patients were randomized to receive monthly injections of lanreotide 120 mg or 0.9% sodium chloride placebo for three years.
Summary · context
All randomized participants were included in the analysis (intention-to-treat).
Show in the study text Report a problemFND-4232079304

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

Registered trials1

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

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT02127437

Lanreotide In Polycystic Kidney Disease Study

Assistance Publique - Hôpitaux de Parisn = 15919 Sept 2014 to 31 Jul 2019

Autosomal Dominant Polycystic Kidney Disease (ADPKD

Trial page ClinicalTrials.govUpdated 8 Apr 2026

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

Subjects

Terms as the source lists them.

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