Evidence map›Paper›PMID 22294512›Full record

Trial reportPediatric blood & cancer2012

Effect of hydroxyurea treatment on renal function parameters: results from the multi-center placebo-controlled BABY HUG clinical trial for infants with sickle cell anemia.

Ofelia Alvarez, Scott T Miller, Winfred C Wang, Zhaoyu Luo, M Beth McCarville, George J Schwartz, Bruce Thompson, Thomas Howard, Rathi V Iyer, Sohail R Rana and 5 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pediatric blood & cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 7 pooled it
3.3field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 7 syntheses or guidelines pooled it, 129 citations in OpenAlex.

  1. Pooled it
  2. Interventions for chronic kidney disease in people with sickle cell disease.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Hydroxyurea (hydroxycarbamide) for sickle cell disease.The Cochrane database of systematic reviews · 2022
    Pooled it
  4. Pooled it
  5. Interventions for chronic kidney disease in people with sickle cell disease.The Cochrane database of systematic reviews · 2017
    Pooled it
  6. Pooled it
  7. Hydroxyurea (hydroxycarbamide) for sickle cell disease.The Cochrane database of systematic reviews · 2017
    Pooled it
  8. Trial
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Management of Kidney Disease with Sickle Cell Disease.Journal of the American Society of Nephrology : JASN · 2025
    Review
  17. Article
  18. Article
  19. Review
  20. Article

2 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 12 institutions in 1 country.

Ofelia AlvarezDivision of Pediatric Hematology, University of Miami, Miami, Florida 33136, USA. oalvarez2@med.miami.edu
Scott T Miller
Winfred C Wang
Zhaoyu Luo
M Beth McCarville
George J Schwartz
Bruce Thompson
Thomas Howard
Rathi V Iyer
Sohail R Rana
Zora R Rogers
Sharada A Sarnaik
Courtney D Thornburg
Russell E Ware
BABY HUG Investigators
Clinical Trials and Surveys Corporation · USSt. Jude Children's Research Hospital · USBaylor College of Medicine · USChildren's Hospital of Michigan · USDuke Medical Center · USHoward University · USKings County Hospital Center · USSouthwestern Medical CenterUniversity of Alabama at Birmingham · USUniversity of Miami Hospital · USUniversity of Mississippi · USUniversity of Rochester Medical Center · US

Funding

CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025008 · NCRR · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2007 to 2011
$29.0M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIAL - MCC-N01HB7160N01HB007160 · HB · CLINICAL TRIALS AND SURVEYS CORPORATION · PI THOMPSON, BRUCE WILLIAM · 2000 to 2006
$638k
PEDIATRIC HYDROXYUERA PHASE III CLINICAL TRIALN01HB007153 · HB · JOHNS HOPKINS UNIVERSITY · PI CASELLA, JAMES F · 2000 to 2000
$116k
PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIALN01HB007157 · HB · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI PEGELOW, CHARLES H · 2000 to 2000
$114k
PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIALN01HB007158 · HB · UNIVERSITY OF MISSISSIPPI MEDICAL CENTER · PI IYER, RATHI V · 2000 to 2000
$112k
PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIALN01HB007151 · HB · DUKE UNIVERSITY · PI WARE, RUSSELL E · 2000 to 2000
$105k
PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIALN01HB007152 · HB · HOWARD UNIVERSITY · PI RANA, SOHAIL · 2000 to 2000
$99k
PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIALN01HB007156 · HB · SUNY DOWNSTATE MEDICAL CENTER · PI MILLER, SCOTT T · 2000 to 2000
$97k
PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIALN01HB007159 · HB · UNIVERSITY OF TEXAS SW MED CTR/DALLAS · PI ROGERS, ZORA · 2000 to 2000
$85k
PEDRIATRIC HYDROXYUREA PHASE III CLINICAL TRIAL CLINICALN01HB007155 · HB · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI WANG, WINFRED C · 2000 to 2001
$82k
PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIALN01HB007154 · HB · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI ABBOUD, MIGUEL R · 2000 to 2000
$80k
NCATS NIH HHS UL1 TR000454NCRR NIH HHS UL1 RR025008NHLBI NIH HHS N01 HB007150NHLBI NIH HHS N01 HB007155NHLBI NIH HHS N01 HB007160NHLBI NIH HHS N01-HB-07150NHLBI NIH HHS N01-HB-07151NHLBI NIH HHS N01-HB-07152NHLBI NIH HHS N01-HB-07153NHLBI NIH HHS N01-HB-07154NHLBI NIH HHS N01-HB-07155NHLBI NIH HHS N01-HB-07156NHLBI NIH HHS N01-HB-07157NHLBI NIH HHS N01-HB-07158NHLBI NIH HHS N01-HB-07159NHLBI NIH HHS N01-HB-07160
6 · The paper itself

Abstract

backgroundChildren with sickle cell anemia (SCA) often develop hyposthenuria and renal hyperfiltration at an early age, possibly contributing to the glomerular injury and renal insufficiency commonly seen later in life. The Phase III randomized double-blinded Clinical Trial of Hydroxyurea in Infants with SCA (BABY HUG) tested the hypothesis that hydroxyurea can prevent kidney dysfunction by reducing hyperfiltration. PROCEDURE: 193 infants with SCA (mean age 13.8 months) received hydroxyurea 20 mg/kg/day or placebo for 24 months. (99m) Tc diethylenetriaminepentaacetic acid (DTPA) clearance, serum creatinine, serum cystatin C, urinalysis, serum and urine osmolality after parent-supervised fluid deprivation, and renal ultrasonography were obtained at baseline and at exit to measure treatment effects on renal function.

resultsAt exit children treated with hydroxyurea had significantly higher urine osmolality (mean 495 mOsm/kg H(2) O compared to 452 in the placebo group, P = 0.007) and a larger percentage of subjects taking hydroxyurea achieved urine osmolality >500 mOsm/kg H(2) O. Moreover, children treated with hydroxyurea had smaller renal volumes (P = 0.007). DTPA-derived glomerular filtration rate (GFR) was not significantly different between the two treatment groups, but was significantly higher than published norms. GFR estimated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula was the best non-invasive method to estimate GFR in these children, as it was the closest to the DTPA-derived GFR.

conclusionTreatment with hydroxyurea for 24 months did not influence GFR in young children with SCA. However, hydroxyurea was associated with better urine concentrating ability and less renal enlargement, suggesting some benefit to renal function.

Indexed as

Anemia, Sickle CellAntisickling AgentsCreatinineCystatin CDouble-Blind MethodFemaleGlomerular Filtration RateHumansHydroxyureaInfantKidneyKidney Failure, ChronicMaleOsmolar ConcentrationRadionuclide ImagingRadiopharmaceuticalsAntisickling AgentsCreatinineCystatin CHydroxyureaRadiopharmaceuticalsTechnetium Tc 99m Pentetate

Identifiers

PMID22294512
PMCPMC3396762
OpenAlexW2065444741

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.