A Double-blind, Proof of Concept Trial of the use of Pegvisomant to Reduce UrinaryAlbumin excretion in Type 1 and Type 2 Diabetic Patients treated with Angiotensin Convertase Inhibitors/Angiotensin receptor blockers, with persistent Albuminuria. - N/A

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials