Three Times Weekly (TIW) Growth Hormone Therapy in Children on Hemodialysis

NCT00943995 | Completed Phase 3 DMC

• 1 other identifier: 907-M02R
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 5

Brief Summary

Hypotheses:

1. 1.The provision of thrice weekly subcutaneous (SQ) recombinant growth hormone (rGH) therapy to children receiving in-center hemodialysis (HD) will result in improved growth.
2. 2.The provision of thrice weekly SQ rGH therapy to children receiving in-center HD will result in improved lean body mass, nutritional status and quality of life.

Conditions

Kidney Failure, Chronic; Renal Dialysis

Keywords

End Stage Kidney Disease; Kidney Failure; Short stature; Growth Hormone therapy

Outcome Measures

Primary Outcomes (1)

• Primary Endpoints: Changes in Height SDS and Height velocity SDS

  Will be monitored every 6 months

Secondary Outcomes (1)

• Changes in Weight SDS, lean body mass, normalized protein catabolic rate and quality of life.

  Will be monitored every 6 months

Study Arms (1)

Treatment Arm

OTHER

Getting Growth Hormone therapy TIW instead of nightly in the Pediatric Tanner 1 Hemodialysis population.

Drug: somatropin

Interventions

somatropin DRUG

0.35 mg/Kg/week divided into 3 doses, each dose being given at the end of the dialysis treatment.

Also known as: Nutropin AQ

Treatment Arm

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Chronic Renal Failure on Hemodialysis
• Tanner 1
• Bone Age \<12
• Below the 3rd %tile for height or have growth velocity \< 3rd %tile and are not on SQ rGH Rx
• At baseline, study population will also have to have documentation of normal thyroid status, secondary hyperparathyroidism will be controlled in acceptable range (iPTH \< 800), adequate dialysis (Kt/V \>1.2) and normal acid-base status.
• expected to be on hemodialysis at least 6 months

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Genentech, Inc.: collaborator

Study Sites (5)

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Children's Memorial Hermann Hospital-TMC

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (9)

• 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.

  PMID: 17554147 BACKGROUND

• Goldstein SL, Currier H, Watters L, Hempe JM, Sheth RD, Silverstein D. Acute and chronic inflammation in pediatric patients receiving hemodialysis. J Pediatr. 2003 Nov;143(5):653-7. doi: 10.1067/S0022-3476(03)00534-1.

  PMID: 14615740 BACKGROUND

• Goldstein SL. Adequacy of dialysis in children: does small solute clearance really matter? Pediatr Nephrol. 2004 Jan;19(1):1-5. doi: 10.1007/s00467-003-1368-x. Epub 2003 Nov 22.

  PMID: 14673636 BACKGROUND

• Goldstein SL, Brem A, Warady BA, Fivush B, Frankenfield D. Comparison of single-pool and equilibrated Kt/V values for pediatric hemodialysis prescription management: analysis from the Centers for Medicare & Medicaid Services Clinical Performance Measures Project. Pediatr Nephrol. 2006 Aug;21(8):1161-6. doi: 10.1007/s00467-006-0112-8. Epub 2006 May 17.

  PMID: 16705459 BACKGROUND

• Gorman G, Frankenfield D, Fivush B, Neu A. Linear growth in pediatric hemodialysis patients. Pediatr Nephrol. 2008 Jan;23(1):123-7. doi: 10.1007/s00467-007-0631-y. Epub 2007 Oct 16.

  PMID: 17934888 BACKGROUND

• Juarez-Congelosi M, Orellana P, Goldstein SL. Normalized protein catabolic rate versus serum albumin as a nutrition status marker in pediatric patients receiving hemodialysis. J Ren Nutr. 2007 Jul;17(4):269-74. doi: 10.1053/j.jrn.2007.04.002.

  PMID: 17586426 BACKGROUND

• Kari JA, Rees L. Growth hormone for children with chronic renal failure and on dialysis. Pediatr Nephrol. 2005 May;20(5):618-21. doi: 10.1007/s00467-004-1801-9. Epub 2005 Mar 22.

  PMID: 15782308 BACKGROUND

• Mahan JD, Warady BA; Consensus Committee. Assessment and treatment of short stature in pediatric patients with chronic kidney disease: a consensus statement. Pediatr Nephrol. 2006 Jul;21(7):917-30. doi: 10.1007/s00467-006-0020-y. Epub 2006 May 30.

  PMID: 16773402 BACKGROUND

• Neu AM, Bedinger M, Fivush BA, Warady BA, Watkins SL, Friedman AL, Brem AS, Goldstein SL, Frankenfield DL. Growth in adolescent hemodialysis patients: data from the Centers for Medicare & Medicaid Services ESRD Clinical Performance Measures Project. Pediatr Nephrol. 2005 Aug;20(8):1156-60. doi: 10.1007/s00467-005-1889-6. Epub 2005 Jun 24.

  PMID: 15977027 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency; Dwarfism

Interventions

Human Growth Hormone; Growth Hormone

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• John D Mahan, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 22, 2009
• Study Start: July 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

US (5)