The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis (OPPORTUNITY)

Novo Nordisk

Status and phase: Terminated; Phase 3

Conditions: Chronic Kidney Disease; End-Stage Renal Disease

Treatments: Drug: placebo; Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00503698

2006-004702-56 (EudraCT Number)

NN1630-1453

Details and patient eligibility

About

This trial is conducted in Africa, Asia, Europe, North and South America and Oceania.

The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on survival (primary end-point; "time to death" and health related quality of life in adult patients on chronic haemodialysis.

Full description

The decision to discontinue the trial is not due to safety concerns. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is expected to have a negative impact on the outcome of the trial.

Enrollment: 712 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Serum albumin as specified in protocol
• Malnourished (based on serum albumin value below 40 g/L, assessed centrally)
• Stable (for 3 months or more) and adequate haemodialysis treatment three months prior to enrolment as defined by Kt/V of more than 1.2

Exclusion criteria

• Active malignant disease
• Critical illness requiring treatment in an intensive care unit (ICU)
• Uncontrolled treated/untreated hypertension
• Patients on chronic (more than 3 months) treatment with steroids in doses of more than 10 mg/day prednisolone (or equivalent)
• Patients treated with immunosuppressive agents
• Known Growth Hormone Deficiency
• Patients suffering from any clinically significant disease history in the opinion of the investigator
• Severe illness as defined in the protocol (as judged by the investigator)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

712 participants in 2 patient groups, including a placebo group

Somatropin

Experimental group

Description:

Somatropin once daily from week 0 to end of trial

Treatment:

Drug: somatropin

Placebo

Placebo Comparator group

Description:

Placebo once daily to end of trial

Treatment:

Drug: placebo