NCT00184652

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2003

Geographic Reach
9 countries

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

2.4 years

First QC Date

September 13, 2005

Last Update Submit

January 23, 2017

Conditions

Chronic Kidney DiseaseEnd-Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

  • Change in surrogate markers of nutrition

    After 6 months treatment

Secondary Outcomes (2)

  • Quality of Life

  • Other markers of nutrition

Interventions

somatropinDRUG

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ESRD patients

You may not qualify if:

  • Diabetes Mellitus
  • Severe and Malignant diseases
  • Patients in Intensive Care Units

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Novo Nordisk Investigational Site

Århus N, 8200, Denmark

Location

Novo Nordisk Investigational Site

København Ø, 2100, Denmark

Location

Novo Nordisk Investigational Site

Odense, 5000, Denmark

Location

Novo Nordisk Investigational Site

Berlin, 13353, Germany

Location

Novo Nordisk Investigational Site

Heidelberg, 69115, Germany

Location

Novo Nordisk Investigational Site

Hong Kong, Hong Kong

Location

Novo Nordisk Investigational Site

Holon, 58100, Israel

Location

Novo Nordisk Investigational Site

Kfar Saba, 44281, Israel

Location

Novo Nordisk Investigational Site

Petah Tikva, 49100, Israel

Location

Novo Nordisk Investigational Site

Ramat Gan, 52621, Israel

Location

Novo Nordisk Investigational Site

Tel Aviv, 64239, Israel

Location

Novo Nordisk Investigational Site

Tzriffin, 70300, Israel

Location

Novo Nordisk Investigational Site

Krakow, 31-501, Poland

Location

Novo Nordisk Investigational Site

Lublin, 20 - 094, Poland

Location

Novo Nordisk Investigational Site

Wołomin, 05-200, Poland

Location

Novo Nordisk Investigational Site

Singapore, 119074, Singapore

Location

Novo Nordisk Investigational Site

Gothenburg, 417 17, Sweden

Location

Novo Nordisk Investigational Site

Bern, 3010, Switzerland

Location

Novo Nordisk Investigational Site

Birmingham, B9 5SS, United Kingdom

Location

Novo Nordisk Investigational Site

Coventry, CV2 2DX, United Kingdom

Location

Novo Nordisk Investigational Site

Glasgow, G11 6NT, United Kingdom

Location

Novo Nordisk Investigational Site

Liverpool, L69 3GA, United Kingdom

Location

Novo Nordisk Investigational Site

Manchester, M13 0HZ, United Kingdom

Location

Novo Nordisk Investigational Site

Newcastle, NE7 7DN, United Kingdom

Location

Novo Nordisk Investigational Site

Sheffield, S5 7AU, United Kingdom

Location

Novo Nordisk Investigational Site

Swansea, SA6 6NL, United Kingdom

Location

Related Publications (1)

  • 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: 17554147RESULT

Related Links

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, Chronic

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

April 1, 2003

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

DE(2)PL(3)SE(1)HK(1)CH(1)IL(6)SG(1)DK(3)GB(8)