Autosomal Dominant Polycystic Kidney Disease (ADPKD Clinical Trial
— LIPSOfficial title:
Lanreotide In Polycystic Kidney Disease Study
| Verified date | November 2019 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 159 |
| Est. completion date | July 31, 2019 |
| Est. primary completion date | July 31, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Necker hospital | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | IPSEN pharmaceutical company, Boulogne-Billancourt, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Glomerular filtration rate (GFR) | month 36 | ||
| Secondary | Glomerular filtration rate (GFR) | month 18 | ||
| Secondary | Glomerular filtration rate (GFR) decline | month 36 | ||
| Secondary | Safety, tolerance | month 36 | ||
| Secondary | Onset or worsening of hypertension | month 18 | ||
| Secondary | Onset or worsening of hypertension | month 36 | ||
| Secondary | Quality of life | SF-36, EQ5D | month 0 | |
| Secondary | Quality of life | SF-36, EQ5D | month 18 | |
| Secondary | Quality of life | SF-36, EQ5D | month 36 | |
| Secondary | Cystic pain | month 36 |