Growth Hormone in Patients on Dialysis
Author Information
Author(s): Langbakke Irene H, Nielsen Jakob N, Skettrup Mia P, Harper Angela, Klitgaard Thomas, Weil Angelika, Engelhardt Eva, Lange Martin
Primary Institution: Novo Nordisk A/S
Hypothesis
The study aimed to investigate the pharmacokinetics and safety of growth hormone treatment in patients with end-stage renal disease (ESRD).
Conclusion
The study found that growth hormone concentrations returned to baseline levels in ESRD patients within 20-22 hours, indicating that it does not accumulate in their circulation.
Supporting Evidence
- GH AUC0–24 h was greater for patients than healthy subjects.
- The terminal half-life was shorter for patients compared to healthy subjects.
- No major safety issues were identified during the trial.
- GH concentrations for both groups were comparable to baseline by 20–22 h.
Takeaway
This study looked at how growth hormone works in patients on dialysis and found that it doesn't stay in their bodies longer than in healthy people.
Methodology
An open, nonrandomized, parallel-group study lasting 8–9 days with 11 ESRD patients and 10 healthy individuals receiving recombinant human GH.
Potential Biases
There were protocol deviations affecting some subjects, but these were not considered to impact the trial results.
Limitations
Endogenous GH secretion was not suppressed, which may have affected the results.
Participant Demographics
{"patients":{"mean_age":51.3,"sex_distribution":{"female":3,"male":8},"race":"White"},"healthy_subjects":{"mean_age":50.2,"sex_distribution":{"female":3,"male":7},"race":"White"}}
Statistical Information
P-Value
0.01
Confidence Interval
1.40; 2.07
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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