Table 3.
Experience with growth hormone injections in patients undergoing maintenance dialysis therapy or with stage 5 chronic kidney disease not on dialysis
| Reference (study design) | N | Dose and duration | Efficacy | Safety |
|---|---|---|---|---|
| Ziegler et al. 1991 (open label, crossover design) (10) | 5 MHD-GH | 5-10 mg 3 × /week for 2 weeks | ↓ Net urea generation, nPNA, and phosphorus ↑ IGF-1 | No reported safety concerns |
| Ikizler et al. 1994 (open label, crossover design) (12) | 10 CAPD -GH | 5 mg subcutaneously daily for 7 consecutive days (∼ 80 μ g/kg per day) | ↓ SUN, urine nitrogen excretion rate, PNA, amino acid concentrations ↓ serum albumin | No AEs reported |
| Garibotto et al. 1997 (open label, crossover design) (13) | 6 MHD-GH | 5 mg subcutaneously 3 × /week for 6 weeks (∼ 2.1 mg/d) | ↑ muscle protein synthesis and net balance | No AEs reported |
| Sohmiya et al. 1998 (open label study) (17) | 8 CKD-GH (patients not on dialysis) | 2 μ g/kg per hour for 72 hours | ↑ in IGF-1 levels, erythropoietin and reticulocyte counts ↓ SUN | No AEs reported |
| Iglesias et al. 1998 (randomized, controlled, prospective trial) (14) | 4 MHD/4 CAPD-GH7 MHD/2 CAPD-PLBO | 0.2 IU/kg per day for 4 weeks (∼ 67 μ g/kg per day) | ↑ 1.2 kg wt gain in GH group No Δ hand grip strength ↓ albumin, total protein, SUN GH group | Pain at the site of injection, headache, nausea, vomiting, hypotension, paresthesisa, and anxiety in the GH treated group |
| Johannsson et al. 1999 (randomized, controlled, prospective trial) (18) | 7 MHD-GH10 MHD-PLBO | 66.7 μ g/kg for 3× /week | No change in weight | No AEs led to reduction of GH dose; 2 subjects in the GH group died of unspecified causes |
| For 6 months (∼ 28.6 μ g/kg per day) | ↑ FFM (3.9 kg), hand grip strength and normal gait speed in the GH-treated group | |||
| Hansen et al, 2000 (randomized, controlled, prospective trial) (16) | 9 MHD-GH | 4I U/m2 per day (∼ 13.7 mg/m2 per day or ∼ 30 μg/kg per day) | ↑ 3.1 kg LBM, ↓ 3.0 kg FM | No AEs observed |
| 11 MHD-PLBO | ||||
| Kotzmann et al. 2001 (randomized, controlled, prospective trial) (19) | 9 MHD-GH | 0.125 IU/kg (∼ 42 μ g/kg) 3 × /week for 4 weeks followed by 0.25 IU/kg (∼ 83 μ g/kg) 3 × /week for 4 weeks over 3 months | No Δ albumin, SUN, creatinine, and anthropometry | Arthralgia in 5 patients on GH, 1 control, headache in 1 patient on GH |
| Iglesias et al. 2002 (open label study) (20) | 4 MHD-GH4 CAPD-GH | 0.2 IU/kg per day (∼ 66.7 μ g/kg per day) subcutaneously for 4 weeks | Significant correlations between leptin and IGF-1 concentration | No AEs reported |
| Ericsson et al. 2004 (randomized, controlled, prospective trial) (21) | 35 MHD-GH | 0.025 IU/kg per day (∼ 8.3 μg/kg per day)for 1 week, increasing to 0.05 IU/kg per day (∼ 16.7 μ g/kg per day) for 8 weeks | ↑ nPCR No Δ in serum albumin and weight | AEs were equally distributed between two groups |
| Pupim et al. 2005 (open label, crossover study) (22) | 7 MHD-GH | 75 μ g/kg per day for 3 consecutive days | ↑ whole-body net protein balance ↓ Essential amino acid concentrations and muscle breakdown | No AEs reported |
| Kopple et al. 2005 (open label study) (23) | 6 MHD-GH | 50 μ g/kg per day subcutaneously for 8-21 days | ↑ IGF-1; ↑ nitrogen balance and ↓ SUN during GH treatment | 2 subjects who were acutely ill appeared to be GH resistant |
| Feldt-Rasmussen et al. 2007 (randomized, controlled, prospective trial) (9) | 105 MHD-GH | Three dose groups (20, 35, and 50 μ g/kg per day) for 6 months | ↑ LBM and ↑ QoL in all GH groups | No difference of SAE across dose groups; no Δ in LV mass |
| 34 MHD-PLBO | ↑ serum albumin in low dose GH group |
MHD, maintenance hemodialysis; CAPD, continuous ambulatory peritoneal dialysis; PLBO, placebo-treated controls; nPNA, normalized protein equivalent of total nitrogen appearance; GH, growth hormone; SUN, serum urea nitrogen; FFM, fat free mass; LBM, lean body mass; QoL, quality of life; LV, left ventricular; AE, adverse event; SAE, serious adverse event.