Clinical trials: sponsored by Mario Negri Institute for Pharmacological Research
Fabry Disease
Enzyme Replacement Therapy in Fabry Disease
Fabry disease is an X-linked rare metabolic disease, caused by a deficient activity of the hydrolase α-Galactosidase A, and characterized by a progressive and systematic deposition of glycosphingolipids in many organs.
- Trial name
- NCT00149318
- Testing
- Biochemical analyses.
- Where
- Italy
- Volunteers
- 2 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Adenocarcinoma of the Stomach, Adenocarcinoma of the Gastroesophageal Junction
Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach
Open label, randomised, multicenter, superiority study for efficacy. Patients with histologically proven adenocarcinoma of the stomach or gastroesophageal junction without gross or microscopic evidence of residual disease after…
- Trial name
- ITACA-S (NCT01640782)
- Testing
- Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin, Leucovorin, 5-Fluorouracil
- Where
- 101 sites in Italy
- Volunteers
- 1,100 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Schizophrenia
Pragmatic RCT Comparing Aripiprazole, Olanzapine and Haloperidol in the Treatment of Schizophrenia
The GiSAS study is a multi-centre randomized clinical trial that will involve about 80 italian community psychiatric services in Italy and will recruit 800 patients affected by schizophrenia.
- Trial name
- GiSAS (NCT01052389)
- Testing
- Aripiprazole, Olanzapine, Haloperidol
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Bronchial Spasm, Respiratory Sounds
Efficacy of Nebulised Beclometasone in Viral Wheezing Prophylaxis
Inhaled steroids, in particular beclomethasone, are widely prescribed in Italy as symptomatic treatment of upper respiratory infections without evidence of efficacy.
- Conditions
- Bronchial Spasm, Respiratory Sounds, Respiratory Tract Infections
- Trial name
- ENBe (NCT01265342)
- Testing
- Beclomethasone
- Where
- 9 sites in Italy
- Volunteers
- 576 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Renal Transplant
Telmisartan Versus Losartan in Kidney Transplantation
In renal transplant recipients, residual renal insufficiency combined to the effects of immunosuppressive therapy with steroids or calcineurin inhibitors may reduce insulin activity and may contribute to several of the…
- Trial name
- COSTANT (NCT01224860)
- Testing
- Telmisartan, Losartan
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Renal Transplantation
CE-US in Renal Transplantation
Acute allograft dysfunction is often observed in the first weeks after kidney transplantation. Renal biopsy is universally considered the gold standard procedure for differential diagnosis of acute allograft dysfunction secondary…
- Trial name
- NCT01815320
- Testing
- Contrast-enhanced ultrasound (CE-US), SonoVue
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Polycystic Kidney
Sirolimus Treatment in Patients With Autosomal Dominant Polycystic Kidney Disease: Renal Efficacy and Safety
Autosomal-Dominant Polycystic Kidney Disease (ADPKD) is the most common hereditary renal disease, characterized by the progressive development of fluid-filled cysts in the kidney leading to progressive loss of renal function and…
- Trial name
- SIRENA (NCT00491517)
- Testing
- Sirolimus, conventional therapy
- Where
- Italy
- Volunteers
- 22 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Somatostatin in Polycystic Kidney: a Long-term Three Year Follow up Study
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common hereditary renal disease, responsible for 8% to 10% of the cases of end stage renal disease (ESRD) in Western countries.
- Trial name
- ALADIN (NCT00309283)
- Testing
- Long-acting somatostatin, Saline solution
- Where
- 5 sites in Italy
- Volunteers
- 78 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Diabetes Type 2, Hypertension
Acetyl-L-Carnitine in Type 2 Diabetes
Decreased insulin sensitivity (or insulin resistance) is a major risk factor for type 2 diabetes mellitus and renal and cardiovascular disease.
- Trial name
- DIABASI (NCT00984750)
- Testing
- acetyl-L-carnitine/statin (simvastatin)
- Where
- 5 sites in Italy
- Volunteers
- 229 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Sirolimus In Autosomal Dominant Polycystic Kidney Disease And Severe Renal Insufficiency
The general aim of this study in adult patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and severe renal insufficiency is to assess the safety and the efficacy of sirolimus (SRL) in slowing renal function…
- Trial name
- SIRENA-II (NCT01223755)
- Testing
- Sirolimus, conventional therapy
- Where
- Italy
- Volunteers
- 41 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Nephrotic Syndrome
Rituximab in Multirelapsing Minimal Change Disease (MCD) or Focal Segmental Glomerulosclerosis (FSGS)
Background. Patients, especially children, with steroid-dependent or multirelapsing nephrotic syndrome (NS) secondary to minimal change disease (MCD) or idiopathic focal and segmental glomerulosclerosis (FSGS) on continuous…
- Trial name
- NEMO (NCT00981838)
- Testing
- Rituximab
- Where
- 7 sites in Italy
- Volunteers
- 24 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Renal Transplant, Secondary Hyperparathyroidism
Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism
The risk of fracture for kidney transplant recipients is 4 times higher that of the general population. The hyperparathyroidism plays a key role in the maintenance or development of post-transplant alterations of bone…
- Trial name
- APPLE (NCT01220050)
- Testing
- Paricalcitol, Standard therapy
- Where
- Italy
- Volunteers
- 43 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Diabetes Mellitus
Preventing Renal Functional Abnormalities With Calorie Restriction in Subjects With Abdominal Obesity and Type 2 Diabetes at Increased Renal and Cardiovascular Risk
The study investigates whether a caloric restricted dietary regime can prevent onset and/or progression of chronic kidney disease in type 2 diabetic patients with abdominal obesity, through the amelioration of concomitant…
- Trial name
- CRESO (NCT01213212)
- Testing
- Caloric restriction, No intervention
- Where
- Italy
- Volunteers
- 73 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Cardiovascular Diseases
Risk and Prevention Study: Evaluation of the Efficacy of n-3 PUFA in Subjects at High Cardiovascular Risk
In the everyday practice cardiovascular prevention in people at high risk is still unsatisfactory and treatments with documented efficacy are generally under-used.
- Trial name
- NCT00317707
- Testing
- N-3 Polyunsaturated Fatty Acids
- Where
- Italy
- Volunteers
- 12,513 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Type 2 Diabetes Mellitus
Acetylcarnitine and Insulin Sensitivity
Decreased insulin sensitivity (e.g. insulin resistance) is a hallmark and a major pathogenic factor of type 2 diabetes. It is the key factor of the metabolic syndrome - a cluster of arterial hypertension, obesity, impaired…
- Trial name
- NCT00393770
- Testing
- L-acetylcarnitine
- Where
- Italy
- Volunteers
- 43 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Chronic Nephropathy, Proteinuria
Statins in Proteinuric Nephropathies
End stage renal disease (ESRD) is rapidly growing worldwide. Patients with ESRD have increased morbidity and mortality mostly because of a dramatic excess of cardiovascular disease.
- Conditions
- Chronic Nephropathy, Proteinuria, Hypertension
- Trial name
- ESPLANADE (NCT00199927)
- Testing
- Fluvastatin, standard therapy
- Where
- 16 sites in Italy
- Volunteers
- 217 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Kidney Transplant
Metabolic and Renal Effects of Rosiglitazone in Kidney Transplant
Abnormalities in glucidic and lipidic metabolism are common features in renal transplant patients on chronic immunossupression with steroids and calcineurin inhibitors.
- Trial name
- NCT00309309
- Testing
- Rosiglitazone
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Type 2 Diabetes
Ezetimibe and Simvastatin in Dyslipidemia of Diabetes
Diabetes mellitus is becoming a global epidemic burden. Its chronic cardiovascular complications, myocardial infarction and stroke, are the main causes of death in diabetic patients.
- Trial name
- NCT00157482
- Testing
- Ezetimibe, Simvastatin
- Where
- 4 sites in Italy
- Volunteers
- 108 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Pre-Eclampsia
L-Arginine in Pre-Eclampsia
Pre-eclampsia is a disorder unique to pregnancy affecting both the mother and the fetus. Hypertension, proteinuria and edema are the most common and well-known maternal clinical symptoms. The incidence is approximately 6-8%.
- Trial name
- NCT00157521
- Testing
- L-arginine
- Where
- 2 sites in Italy
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research
Kidney Transplant
Low Dose Sirolimus or CsA-Based Maintenance Immunosuppression After Induction With Campath-1 in Kidney Transplantation
During the past 15 years, however, the superior immunosuppressive efficacy of CsA and the well-known toxicity of long-term steroid therapy have prompted trials of steroid withdrawal from renal allograft recipients at various…
- Trial name
- NCT00309270
- Testing
- Campath-1H
- Where
- Italy
- Volunteers
- 21 people
- Sponsor
- Mario Negri Institute for Pharmacological Research