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| Name | Class |
|---|---|
| IPSEN pharmaceutical company, Boulogne-Billancourt, France | UNKNOWN |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - treated group | Experimental |
| |
| B - control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanreotide | Drug | 120 mg, subcutaneously, once every 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular filtration rate (GFR) | month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular filtration rate (GFR) | month 18 | |
| Glomerular filtration rate (GFR) decline | month 36 | |
| Safety, tolerance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique JOLY, MD, PhD | Necker hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Necker hospital | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42320793 | Derived | 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. | |
| 39356039 |
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| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C060347 | lanreotide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| saline |
| Drug |
0,5 ml, subcutaneously, once every 4 weeks |
|
| month 36 |
| Onset or worsening of hypertension | month 18 |
| Onset or worsening of hypertension | month 36 |
| Quality of life | SF-36, EQ5D | month 0 |
| Quality of life | SF-36, EQ5D | month 18 |
| Quality of life | SF-36, EQ5D | month 36 |
| Cystic pain | month 36 |
| Derived |
| St 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
| D017670 |
| Sodium Compounds |