Effect of Lanreotide on Kidney Function in Patients With Autosomal Dominant Polycystic Kidney Disease: The DIPAK 1 Randomized Clinical Trial.

Meijer E, Visser FW, van Aerts RMM, Blijdorp CJ, Casteleijn NF, D'Agnolo HMA, Dekker SEI, Drenth JPH, de Fijter JW, van Gastel MDA, Gevers TJ, Lantinga MA and 11 more

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Losekoot M, Messchendorp AL, Neijenhuis MK, Pena MJ, Peters DJM, Salih M, Soonawala D, Spithoven EM, Wetzels JF, Zietse R, Gansevoort RT

JAMA1 Nov 2018Cited by 100 (Europe PMC)

PMID30422235PMCIDPMC6248170DOI10.1001/jama.2018.15870PepBankPUB-30422235

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In ADPKD patients, annual eGFR decline was similar with lanreotide and standard care (-3.53 versus -3.46 mL/min/1.73 m2 per year, difference -0.08, 95% CI -0.71 to 0.56, P=.81).
In plain wordsLanreotide did not significantly change annual kidney function decline compared with standard care.
Peptide
Lanreotide
Outcome
No significant changeAnnual eGFR decline
Study
n = 309
Comparator
Standard care
Analysis
Primary
Outcome group
Kidney function · Kidney and urinary
Studied dose
120 mg every 4 weeks · subcutaneous · 2.5 yearsAs given in this study (human).
Measurements
annual eGFR decline
−3.53 mL/min/1.73 m2 per year
lanreotide
annual eGFR decline
−3.46 mL/min/1.73 m2 per year
control
difference in annual eGFR decline
−0.08 mL/min/1.73 m2 per year
lanreotide vs control; 95% CI -0.71 to 0.56
95% CI of difference
−0.71 to 0.56 mL/min/1.73 m2 per year
lanreotide vs control
Source sentences
Summary
Annual rate of eGFR decline for the lanreotide vs the control group was -3.53 vs -3.46 mL/min/1.73 m2 per year (difference, -0.08 [95% CI, -0.71 to 0.56]; P = .81).
2 context sentences(design, population, supporting numbers)
Summary · context
An open-label randomized clinical trial with blinded end point assessment that included 309 patients with ADPKD from July 2012 to March 2015 at 4 nephrology outpatient clinics in the Netherlands.
Summary · context
Patients were randomized to receive either lanreotide (120 mg subcutaneously once every 4 weeks) in addition to standard care (n = 153) or standard care only (target blood pressure <140/90 mm Hg; n = 152).
Report a problemFND-3042223501
02HumanRandomized controlled trialEfficacy outcome
In ADPKD patients, lanreotide did not significantly change worsening kidney function versus control (HR 0.87, CI 0.49 to 1.52, P=.87).
In plain wordsLanreotide did not significantly change worsening kidney function compared with standard care.
Peptide
Lanreotide
Outcome
No significant changeWorsening kidney function
Study
n = 309
Comparator
Standard care
Analysis
Secondary
Outcome group
Kidney function · Kidney and urinary
Studied dose
120 mg every 4 weeks · subcutaneous · 2.5 yearsAs given in this study (human).
Measurements
hazard ratio (worsening kidney function)
0.87
lanreotide vs control; 95% CI 0.49 to 1.52
95% CI of hazard ratio
0.49 to 1.52
lanreotide vs control
Source sentences
Summary
There were no significant differences for incidence of worsening kidney function (hazard ratio, 0.87 [95% CI, 0.49 to 1.52]; P = .87)
2 context sentences(design, population, supporting numbers)
Summary · context
An open-label randomized clinical trial with blinded end point assessment that included 309 patients with ADPKD from July 2012 to March 2015 at 4 nephrology outpatient clinics in the Netherlands.
Summary · context
Patients were randomized to receive either lanreotide (120 mg subcutaneously once every 4 weeks) in addition to standard care (n = 153) or standard care only (target blood pressure <140/90 mm Hg; n = 152).
Report a problemFND-3042223502
03HumanRandomized controlled trialEfficacy outcome
In ADPKD patients, eGFR change was similar with lanreotide and standard care (-3.58 versus -3.45, difference -0.13 mL/min/1.73 m2 per year, 95% CI -1.76 to 1.50, P=.88).
In plain wordsKidney function changes did not differ significantly between lanreotide and standard care.
Peptide
Lanreotide
Outcome
No significant changeeGFR change before versus after treatment
Study
n = 309
Comparator
Standard care
Analysis
Secondary
Outcome group
Kidney function · Kidney and urinary
Studied dose
120 mg every 4 weeks · subcutaneous · 2.5 yearsAs given in this study (human).
Measurements
change in eGFR
−3.58 mL/min/1.73 m2 per year
lanreotide
change in eGFR
−3.45 mL/min/1.73 m2 per year
control
difference in eGFR change
−0.13 mL/min/1.73 m2 per year
lanreotide vs control; 95% CI -1.76 to 1.50
95% CI of difference
−1.76 to 1.5 mL/min/1.73 m2 per year
lanreotide vs control
Source sentences
Summary
change in eGFR (-3.58 vs -3.45; difference, -0.13 mL/min/1.73 m2 per year [95% CI, -1.76 to 1.50]; P = .88)
2 context sentences(design, population, supporting numbers)
Summary · context
An open-label randomized clinical trial with blinded end point assessment that included 309 patients with ADPKD from July 2012 to March 2015 at 4 nephrology outpatient clinics in the Netherlands.
Summary · context
Patients were randomized to receive either lanreotide (120 mg subcutaneously once every 4 weeks) in addition to standard care (n = 153) or standard care only (target blood pressure <140/90 mm Hg; n = 152).
Report a problemFND-3042223503
04HumanRandomized controlled trialEfficacy outcome
In ADPKD patients, quality-of-life change did not differ with lanreotide versus control (0.05 versus 0.07, difference -0.03, CI -0.13 to 0.08, P=.67).
In plain wordsQuality of life did not change significantly with lanreotide compared with standard care.
Peptide
Lanreotide
Outcome
No significant changeQuality of life change
Study
n = 309
Comparator
Standard care
Analysis
Secondary
Outcome group
Quality of life · Whole body
Studied dose
120 mg every 4 weeks · subcutaneous · 2.5 yearsAs given in this study (human).
Measurements
change in quality of life
0.05 units
lanreotide
change in quality of life
0.07 units
control
difference in quality-of-life change
−0.03 units per year
lanreotide vs control; 95% CI -0.13 to 0.08
95% CI of difference
−0.13 to 0.08 units per year
lanreotide vs control
Source sentences
Summary
and change in quality of life (0.05 vs 0.07; difference, -0.03 units per year [95% CI, -0.13 to 0.08]; P = .67).
2 context sentences(design, population, supporting numbers)
Summary · context
An open-label randomized clinical trial with blinded end point assessment that included 309 patients with ADPKD from July 2012 to March 2015 at 4 nephrology outpatient clinics in the Netherlands.
Summary · context
Patients were randomized to receive either lanreotide (120 mg subcutaneously once every 4 weeks) in addition to standard care (n = 153) or standard care only (target blood pressure <140/90 mm Hg; n = 152).
Report a problemFND-3042223504
05HumanRandomized controlled trialEfficacy outcome
In ADPKD patients, kidney volume growth was lower with lanreotide versus control (4.15% versus 5.56%, difference -1.33% yearly, CI -2.41% to -0.24%, P=.02).
In plain wordsKidney volume grew more slowly with lanreotide than with standard care.
Peptide
Lanreotide
Outcome
DecreaseTotal kidney volume growth
Study
n = 309
Comparator
Standard care
Analysis
Secondary
Outcome group
Kidney function · Kidney and urinary
Studied dose
120 mg every 4 weeks · subcutaneous · 2.5 yearsAs given in this study (human).
Measurements
growth rate of total kidney volume
4.15%
lanreotide
growth rate of total kidney volume
5.56%
control
difference in kidney volume growth
−1.33 % per year
lanreotide vs control; 95% CI -2.41 to -0.24
95% CI of difference
−2.41 to −0.24 % per year
lanreotide vs control
Source sentences
Summary
The rate of growth in total kidney volume was lower in the lanreotide group than the control group (4.15% vs 5.56%; difference, -1.33% per year [95% CI, -2.41% to -0.24%]; P = .02).
2 context sentences(design, population, supporting numbers)
Summary · context
An open-label randomized clinical trial with blinded end point assessment that included 309 patients with ADPKD from July 2012 to March 2015 at 4 nephrology outpatient clinics in the Netherlands.
Summary · context
Patients were randomized to receive either lanreotide (120 mg subcutaneously once every 4 weeks) in addition to standard care (n = 153) or standard care only (target blood pressure <140/90 mm Hg; n = 152).
Report a problemFND-3042223505
06HumanRandomized controlled trialSafety outcome
In ADPKD patients, injection site discomfort occurred in 32% with lanreotide versus 0.7% with control.
In plain wordsInjection site discomfort occurred more often with lanreotide than with standard care.
Peptide
Lanreotide
Outcome
IncreaseInjection site discomfort
Study
n: not reported in source
Comparator
Standard care
Outcome group
Adverse events · Skin and wound
Studied dose
120 mg every 4 weeks · subcutaneous · 2.5 yearsAs given in this study (human).
Measurements
injection site discomfort incidence
32%
lanreotide plus standard care
injection site discomfort incidence
0.7%
standard care only
Source sentences
Summary
Adverse events in the lanreotide vs control group included injection site discomfort (32% vs 0.7%), injection site papule (5.9% vs 0%), loose stools (91% vs 6.6%), abdominal discomfort (79% vs 20%), and hepatic cyst infections (5.2% vs 0%).
2 context sentences(design, population, supporting numbers)
Summary · context
An open-label randomized clinical trial with blinded end point assessment that included 309 patients with ADPKD from July 2012 to March 2015 at 4 nephrology outpatient clinics in the Netherlands.
Summary · context
Patients were randomized to receive either lanreotide (120 mg subcutaneously once every 4 weeks) in addition to standard care (n = 153) or standard care only (target blood pressure <140/90 mm Hg; n = 152).
Report a problemFND-3042223506
07HumanRandomized controlled trialSafety outcome
In ADPKD patients, injection site papules occurred in 5.9% with lanreotide versus 0% with control.
In plain wordsInjection site papules occurred more often with lanreotide than with standard care.
Peptide
Lanreotide
Outcome
IncreaseInjection site papule
Study
n: not reported in source
Comparator
Standard care
Outcome group
Adverse events · Skin and wound
Studied dose
120 mg every 4 weeks · subcutaneous · 2.5 yearsAs given in this study (human).
Measurements
injection site papule incidence
5.9%
lanreotide plus standard care
injection site papule incidence
0%
standard care only
Source sentences
Summary
Adverse events in the lanreotide vs control group included injection site discomfort (32% vs 0.7%), injection site papule (5.9% vs 0%), loose stools (91% vs 6.6%), abdominal discomfort (79% vs 20%), and hepatic cyst infections (5.2% vs 0%).
2 context sentences(design, population, supporting numbers)
Summary · context
An open-label randomized clinical trial with blinded end point assessment that included 309 patients with ADPKD from July 2012 to March 2015 at 4 nephrology outpatient clinics in the Netherlands.
Summary · context
Patients were randomized to receive either lanreotide (120 mg subcutaneously once every 4 weeks) in addition to standard care (n = 153) or standard care only (target blood pressure <140/90 mm Hg; n = 152).
Report a problemFND-3042223507
08HumanRandomized controlled trialSafety outcome
In ADPKD patients, loose stools occurred in 91% with lanreotide versus 6.6% with control.
In plain wordsLoose stools occurred more often with lanreotide than with standard care.
Peptide
Lanreotide
Outcome
IncreaseLoose stools
Study
n: not reported in source
Comparator
Standard care
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
120 mg every 4 weeks · subcutaneous · 2.5 yearsAs given in this study (human).
Measurements
loose stools incidence
91%
lanreotide plus standard care
loose stools incidence
6.6%
standard care only
Source sentences
Summary
Adverse events in the lanreotide vs control group included injection site discomfort (32% vs 0.7%), injection site papule (5.9% vs 0%), loose stools (91% vs 6.6%), abdominal discomfort (79% vs 20%), and hepatic cyst infections (5.2% vs 0%).
2 context sentences(design, population, supporting numbers)
Summary · context
An open-label randomized clinical trial with blinded end point assessment that included 309 patients with ADPKD from July 2012 to March 2015 at 4 nephrology outpatient clinics in the Netherlands.
Summary · context
Patients were randomized to receive either lanreotide (120 mg subcutaneously once every 4 weeks) in addition to standard care (n = 153) or standard care only (target blood pressure <140/90 mm Hg; n = 152).
Report a problemFND-3042223508
09HumanRandomized controlled trialSafety outcome
In ADPKD patients, abdominal discomfort occurred in 79% with lanreotide versus 20% with control.
In plain wordsAbdominal discomfort occurred more often with lanreotide than with standard care.
Peptide
Lanreotide
Outcome
IncreaseAbdominal discomfort
Study
n: not reported in source
Comparator
Standard care
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
120 mg every 4 weeks · subcutaneous · 2.5 yearsAs given in this study (human).
Measurements
abdominal discomfort incidence
79%
lanreotide plus standard care
abdominal discomfort incidence
20%
standard care only
Source sentences
Summary
Adverse events in the lanreotide vs control group included injection site discomfort (32% vs 0.7%), injection site papule (5.9% vs 0%), loose stools (91% vs 6.6%), abdominal discomfort (79% vs 20%), and hepatic cyst infections (5.2% vs 0%).
2 context sentences(design, population, supporting numbers)
Summary · context
An open-label randomized clinical trial with blinded end point assessment that included 309 patients with ADPKD from July 2012 to March 2015 at 4 nephrology outpatient clinics in the Netherlands.
Summary · context
Patients were randomized to receive either lanreotide (120 mg subcutaneously once every 4 weeks) in addition to standard care (n = 153) or standard care only (target blood pressure <140/90 mm Hg; n = 152).
Report a problemFND-3042223509
10HumanRandomized controlled trialSafety outcome
In ADPKD patients, hepatic cyst infections occurred in 5.2% with lanreotide versus 0% with control.
In plain wordsHepatic cyst infections occurred more often with lanreotide than with standard care.
Peptide
Lanreotide
Outcome
IncreaseHepatic cyst infection
Study
n: not reported in source
Comparator
Standard care
Outcome group
Adverse events · Liver
Studied dose
120 mg every 4 weeks · subcutaneous · 2.5 yearsAs given in this study (human).
Measurements
hepatic cyst infection incidence
5.2%
lanreotide plus standard care
hepatic cyst infection incidence
0%
standard care only
Source sentences
Summary
Adverse events in the lanreotide vs control group included injection site discomfort (32% vs 0.7%), injection site papule (5.9% vs 0%), loose stools (91% vs 6.6%), abdominal discomfort (79% vs 20%), and hepatic cyst infections (5.2% vs 0%).
2 context sentences(design, population, supporting numbers)
Summary · context
An open-label randomized clinical trial with blinded end point assessment that included 309 patients with ADPKD from July 2012 to March 2015 at 4 nephrology outpatient clinics in the Netherlands.
Summary · context
Patients were randomized to receive either lanreotide (120 mg subcutaneously once every 4 weeks) in addition to standard care (n = 153) or standard care only (target blood pressure <140/90 mm Hg; n = 152).
Report a problemFND-3042223510

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

Status unknownPhase 3NCT01616927

Study of Lanreotide to Treat Polycystic Kidney Disease

University Medical Center Groningenn = 300Jun 2012 to est. Dec 2017

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Trial page ClinicalTrials.govUpdated 23 May 2017

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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