Diabetic nephropathy DN (Diabetes mellitus (DM) type I and type II with renal manifestations). MedDRA classification code : 10061835, 10045236 and 10045250 (Version 7.0, Level LLT)
Conditions
Interventions
Trade Name: Somavert 10mg powder for solution for injection
Product Name: Somavert
Product Code: PN-800,467
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Pegvisomant
Curr
Sponsors
Pfizer Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female subjects between the ages of 18-70 years, with Type 1 or Type 2 DM and persistent albuminuria UACR = 3 mg/ mmol. 2.Stable treatment with ACEI or ARB for at least 6 months. 3.Serum creatinine 88-265 µmol/L (1.0-3.0 mg/dL) or GFR= 30 ml/min. 4.Subject must be willing to perform regular home blood glucose monitoring according to local clinical practice. 5.Subject must be willing and able to provide informed consent. 6.Subject must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other programme procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Additional biopsy-proven renal pathology to DN. 2. Untreated proliferative diabetic retinopathy, as assessed in the clinic. 3. Combined ACEI/ARB treatment. 4. Uncontrolled hypertension BP =160/90, despite treatment with 3 anti-hypertensive medications. 5. Proteinuria = 5g/24 hr. 6. Labile glycaemic control as assessed by the trial investigator. 7. Recurrent hypoglycaemia and loss of hypoglycaemic awareness. 8. Other conditions that may result in abnormal GH and/or IGF-1 concentrations (e.g. acromegaly, severe hepatic disease, malnutrition (BMI = 18), morbid obesity (BMI =40), treatment with levodopa). 9. Secondary diabetes mellitus (e.g. thalassaemia major, cystic fibrosis, Cushing’s syndrome). 10. Oral or parenteral steroid treatment ongoing, or for longer than 6 weeks within last 3 months of trial. 11. Serum ALT and, or AST = 5x ULN, or clinically significant hepatic disease. 12. History of relevant drug and/or food allergies or are on regular treatment with any medication that might be expected to interfere with projected programme results. 13. Female of child-bearing potential who is unwilling or unable to use adequate contraception to prevent pregnancy during the programme. 14. Participation in another clinical trial in the last 6 months. 15. Subjects who have donated blood during the previous month or intend to donate blood or blood products during the trial, or for one month following the completion of the trial. 16. Known or suspected alcohol or drug abuse. 17. Female who is or may be pregnant or is lactating. 18. Subject has known or suspected latex allergy. 19. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish that Pegvisomant causes a clinically meaningful decrease in urinary albumin creatinine ratio (UACR) beyond that provided by ACEIs and ARBs. A clinically meaningful decrease is defined as either a 30% average decrease in UACR or a significant percentage of subjects (=70%) showing a 30% decrease in UACR.;Secondary Objective: To demonstrate improvements in renal function and glycaemic control. To demonstrate the safety of pegvisomant in the treatment of subjects with diabetic nephropathy.;Primary end point(s): Proportion of subjects whose UACR fell by = 30% from baseline to 24 weeks. | — |
Countries
Czech Republic, Denmark, Germany, Lithuania, Spain
Outcome results
None listed