Autosomal Dominant Polycystic Kidney Disease (ADPKDPhase 3LIPSNCT02127437
Lanreotide In Polycystic Kidney Disease Study
A Phase 3 study testing Lanreotide and saline in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized double blind placebo controlled study. The main objective is to prove that lanreotide, a somatostatin analog, is able to reduce the glomerular filtration rate decline over 3 years by at least 30%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease (ADPKD
- What is being tested?
- Lanreotide and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2014to 31 Jul 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- autosomal dominant polycystic kidney disease (clinical, familial, imaging grounds)
- measured GFR : 30 to 89 ml/mn/1.73m2
- age > 18
- affiliated with health insurance
- written informed consent
Who cannot join
- iohexol /iodine allergy
- diabetes mellitus
- other associated nephropathy suspected
- evolutive or recent malignant disease ( in the previous 5 years)
- cholelithiasis
- uncontrolled hypertension (BP>160/100 mmHg)
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- cardiac failure of grade III or IV according to the NYHA (New York Heart Association) classification
- liver failure
- psychiatric illness
- pregnancy, lactation, lack of contraception
- use of somatostatin analogs during the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized double blind placebo controlled study. The main objective is to prove that lanreotide, a somatostatin analog, is able to reduce the glomerular filtration rate decline over 3 years by at least 30%. Cardiovascular outcomes, blood pressure, quality of life and safety are among the secondary outcomes. The study, which will include 180 ADPKD patients, is scheduled to start in early 2014.
An equal number of patients with chronic kidney disease stage 2 (90 patients with GFR 89 to 60 ml/mn/1.73 m2) and chronic kidney disease stage 3 (90 patients with GFR 59 to 30 ml/mn/1.73 m2) will be included. The primary endpoint (GFR decline) will be assessed by repeated measures, in the overall population as well as in the two GFR stratus.
- Being tested
- Lanreotide, saline
- Keywords
- Autosomal dominant polycystic kidney disease,, Glomerular filtration rate,, Somatostatin,, lanreotide
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LanreotideDrug
120 mg, subcutaneously, once every 4 weeks
salineDrug
0,5 ml, subcutaneously, once every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| A - treated group | Experimental | Not described Receives: Drug: Lanreotide |
| B - control group | Placebo comparator | Not described Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate (GFR)
Measured: month 36
Secondary outcomes (9)
Glomerular filtration rate (GFR)
Measured: month 18
Glomerular filtration rate (GFR) decline
Measured: month 36
Safety, tolerance
Measured: month 36
Onset or worsening of hypertension
Measured: month 18
Onset or worsening of hypertension
Measured: month 36
Quality of life
SF-36, EQ5D
Measured: month 0
Quality of life
SF-36, EQ5D
Measured: month 18
Quality of life
SF-36, EQ5D
Measured: month 36
Cystic pain
Measured: month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study start19 Sep 2014
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autosomal Dominant Polycystic Kidney Disease (ADPKDStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- IPSEN pharmaceutical company, Boulogne-Billancourt, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Dominique JOLY, MD, PhD, Principal investigator, Necker hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127437
- Sponsor's protocol ID
- LIPS-01
- Acronym
- LIPS
- Status last verified
- Nov 2019
- First submitted
- 2 Apr 2014
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Joly D, Ursino M, Bienaime F, El Karoui K, Karras A, Thervet E, Boffa JJ, Galichon P, Luque Y, Michel PA, Cartery C, Vrtovsnik F, Daugas E, Peraldi MN, Colas S, Semeraro M, Treluyer JM, Meyzer C, Hummel A, Fouchard M, Nguyen-Khoa T, Knebelmann B, Alberti C. A three-year randomized, double-blind, placebo-controlled study of lanreotide in stage 2/3 autosomal dominant polycystic kidney disease. Kidney Int. 2026 Jun 19:S0085-2538(26)00498-9. doi: 10.1016/j.kint.2026.05.018. Online ahead of print.
PubMed 42320793St 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.
PubMed 39356039
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lanreotide In Polycystic Kidney Disease Study
- ClinicalTrials.gov ID
- NCT02127437
- Acronym / sponsor ID
- LIPS / LIPS-01
- Keywords
- Autosomal dominant polycystic kidney disease,, Glomerular filtration rate,, Somatostatin,, lanreotide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- IPSEN pharmaceutical company, Boulogne-Billancourt, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 19 Sep 2014 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized double blind placebo controlled study. The main objective is to prove that lanreotide, a somatostatin analog, is able to reduce the glomerular filtration rate decline over 3 years by at least 30%. Cardiovascular outcomes, blood pressure, quality of life and safety are among the secondary outcomes. The study, which will include 180 ADPKD patients, is scheduled to start in early 2014.
An equal number of patients with chronic kidney disease stage 2 (90 patients with GFR 89 to 60 ml/mn/1.73 m2) and chronic kidney disease stage 3 (90 patients with GFR 59 to 30 ml/mn/1.73 m2) will be included. The primary endpoint (GFR decline) will be assessed by repeated measures, in the overall population as well as in the two GFR stratus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - treated group | Experimental | Drug: Lanreotide |
| B - control group | Placebo comparator | Drug: saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- autosomal dominant polycystic kidney disease (clinical, familial, imaging grounds)
- measured GFR : 30 to 89 ml/mn/1.73m2
- age > 18
- affiliated with health insurance
- written informed consent
Key exclusion criteria (11 listed)
- iohexol /iodine allergy
- diabetes mellitus
- other associated nephropathy suspected
- evolutive or recent malignant disease ( in the previous 5 years)
- cholelithiasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lanreotide120 mg, subcutaneously, once every 4 weeks | Drug | A - treated group |
| saline0,5 ml, subcutaneously, once every 4 weeks | Drug | B - control group |
Primary outcome
Glomerular filtration rate (GFR)
Time frame: month 36
9 secondary outcomes
Glomerular filtration rate (GFR)
Time frame: month 18
Glomerular filtration rate (GFR) decline
Time frame: month 36
Safety, tolerance
Time frame: month 36
Onset or worsening of hypertension
Time frame: month 18
Onset or worsening of hypertension
Time frame: month 36
Quality of life
Time frame: month 0
Quality of life
Time frame: month 18
Quality of life
Time frame: month 36
Cystic pain
Time frame: month 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 42320793Joly D, Ursino M, Bienaime F, El Karoui K, Karras A, Thervet E, Boffa JJ, Galichon P, Luque Y, Michel PA, Cartery C, Vrtovsnik F, Daugas E, Peraldi MN, Colas S, Semeraro M, Treluyer JM, Meyzer C, Hummel A, Fouchard M, Nguyen-Khoa T, Knebelmann B, Alberti C. A three-year randomized, double-blind, placebo-controlled study of lanreotide in stage 2/3 autosomal dominant polycystic kidney disease. Kidney Int. 2026 Jun 19:S0085-2538(26)00498-9. doi: 10.1016/j.kint.2026.05.018. Online ahead of print.
- Derived from this study: PubMed 39356039St 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique JOLY, MD, PhD principal investigator
Necker hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lanreotide and saline in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular filtration rate (GFR) (time frame: month 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02127437, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.