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OpenTrials
Completed

NCT Number: NCT01502137

Pharmacokinetics of Somatropin in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis

This trial is conducted in Europe. The aim of this trial is to to compare steady-state total growth hormone (GH) exposure in haemodialysis (HD) patients with that of matched healthy subjects.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes End-stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Healthy Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

München, 81241, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PATIENTS:
  • Male or female, age equal to or above 18 years undergoing chronic haemodialysis
  • Stable and adequate haemodialysis treatment three months prior to enrolment
  • HEALTHY SUBJECTS:
  • Matching an individual of the patient group by: Gender and age (± 5 years)
  • Matching an individual of the patient group by weight (after dialysis, ±10%)
  • Creatinine clearance above 80 ml/min
  • Subjects must be in good health in accordance with their age as determined by a medical
  • history, physical examination, vital signs, ECG (electrocardiogram), routine haematology and clinical chemistry

Exclusion criteria

  • Use of cuprophane membranes
  • Active malignant disease
  • Diabetes
  • Critical illness as defined by the need of respiratory or circulatory support
  • Known or suspected allergy to the trial product
  • Pregnancy, breast feeding, the intention of becoming pregnant or fertile women judged to be
  • using inadequate contraceptive measures
  • Blood Pressure (pre-dialysis) above 180/110
  • Chronic treatment with steroids in doses above 10 mg/day prednisolone (or equivalent)
  • Treated with immunosuppressive agents

Treatment and study plan

Somatropin

Drug

Injected subcutaneously, 50 mcg/kg/day (up to a maximum of 4 mg/day) once daily. Additional dose administered during dialysis. In total, patients will receive 8 doses.

Primary outcomes

  1. Growth hormone exposure at steady state

Secondary outcomes

  1. Area under the Curve (AUC)

  2. t½ (terminal half-life)

  3. Cmax (maximum plasma concentration)

  4. tmax (time to reach maximum)

  5. IGF-I (Insulin-Like Growth Factor I)

  6. Adverse events (AE)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Open, Non-randomized, Single-centre, Parallel Group Trial Investigating the Steady-state Blood Concentration Profile and Effects of Once Daily Subcutaneously Injected Recombinant Human Growth Hormone (Norditropin® SimpleXx®) in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis and in Matched Healthy Subjects

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Dec 30, 2011
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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