E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To demonstrate improvements in renal function and glycaemic control.
To demonstrate the safety of pegvisomant in the treatment of subjects with diabetic nephropathy. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects whose UACR fell by ≥ 30% from baseline to 24 weeks. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |