Growth Hormone Treatment in Adult Patients With Chronic Kidney Disease

Phase 2 Completed 140 enrolled Novo Nordisk A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

This trial is conducted in Asia, Europe, and Middle East. Adult patients with chronic kidney disease are treated with growth hormone to assess effect on nutritional status.

Timeline

Start: 2003-04
Primary completion: 2005-09
Completion: 2005-09

Outcome

Mixed primary results

paper Change in LBM and serum albumin (primary outcomes), health-related quality of life, and secondary efficacy and safety parameters were monitored. PMID 17554147 ↗

paper 2.5 kg [95% confidence interval 1.8 to 3.1] versus -0.4 kg [95% confidence interval -1.4 to 0.6]; P < 0.001 for pooled hGH groups versus placebo). PMID 17554147 ↗

paper Serum albumin tended to increase (P = 0.076), PMID 17554147 ↗

Publications

Results Feldt-Rasmussen B, Lange M, Sulowicz W, Gafter U, Lai KN, Wiedemann J, Christiansen JS, El Nahas M; APCD Study Group. Growth hormone treatment during hemodialysis in a randomized trial improves nutrition, quality of life, and cardiovascular risk. J Am Soc Nephrol. 2007 Jul;18(7):2161-71. doi: 10.1681/ASN.2006111207. Epub 2007 Jun 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Somatropin	Protein / enzyme biologic	20 ug/kg	—
Subject	Somatropin	Protein / enzyme biologic	35 ug/kg	—
Subject	Somatropin	Protein / enzyme biologic	50 ug/kg	—