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  • Clinical Research Article
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Growth hormone treatment in pre-pubertal short Chinese children with chronic kidney disease prior to transplantation

Pediatric Research volume 94, pages 268–274 (2023)Cite this article

Abstract

Background

The effect of recombinant human GH (rhGH) in Chinese children with chronic kidney disease (CKD) is unclear.

Methods

This was a 52-week, multicenter, randomized, open-label, negative-controlled phase 3 study. Prepubertal subjects were randomized 1:1 to either daily subcutaneous injections of rhGH 0.05 mg/kg/day or no treatment for 52 weeks.

Results

A total of 68 subjects with a mean age of 7.8 ± 3.27 years were enrolled. At week 52, the height standard deviation score (HT-SDS) in the treated group increased by 0.75 ± 0.58, which was significantly higher compared with 0.17 ± 0.47 in the untreated group (least squares mean 0.58, 95% confidence interval, 0.32–0.84; P < 0.001). At week 52, significant improvements were observed in other growth parameters (height velocity [P < 0.001]), insulin-like growth factor 1 (IGF-1) SDS [P < 0.001], IFG-1/insulin-like growth factor binding protein-3 molar ratio [P < 0.001], and height [P < 0.001]) compared with the untreated control. Seven patients reported treatment-related adverse events (TRAEs) and most TRAEs were mild in severity. Most subjects recovered without further intervention.

Conclusions

Daily rhGH for 52 weeks in children with CKD-induced growth retardation significantly improved HT-SDS and other growth parameters without compromising safety.

Impact

  • The efficacy and safety of growth hormone (GH) therapy in Chinese children with chronic kidney disease (CKD) are unclear.

  • This study found that giving short stature Chinese children with CKD daily recombinant human growth hormone (rhGH) for 52 weeks improved growth parameters without compromising safety.

  • This study’s information can give physicians the confidence to treat these patients in their clinical practice.

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Fig. 1: Patient disposition.
Fig. 2: Effect of treatment on growth parameters.

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Data availability

The datasets generated during and/or analyzed during the current study are not publicly available due individual privacy of clinical trial participants should be protected but are available from the corresponding author on reasonable request.

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Acknowledgements

We sincerely thank the patients who participated in this study and their families and all personnel at each study site who cared for the patients and coordinated with the sponsor to make this trial possible. We thank Feihong Luo and Ruoqian Cheng of Children’s Hospital of Fudan University for Tanner stage assessment, and Ping Yin of Huazhong University of Science and Technology for assisting the statistical work. We thank Mengmeng Chen of GeneScience Pharmaceuticals for editorial assistance; Lawrence Law of Parexel for medical writing support.

Funding

This research was funded by GeneScience Pharmaceuticals. The funder was involved in the design and conduct of the study; collection, management, analysis; review of the manuscript; and decision to submit the manuscript for publication.

Author information

Author notes

  1. These authors contributed equally: Xiaoshan Tang, Qiuxia Chen, Qian Shen, Hong Xu.

Authors and Affiliations

  1. Department of Nephrology, Children’s Hospital of Fudan University, Shanghai Kidney Development and Pediatric Kidney Disease Research Center, National Children’s Medical Center, Shanghai, China

    Xiaoshan Tang, Jing Chen, Xiaoyan Fang, Qian Shen & Hong Xu

  2. Department of Nephrology, Children’s Hospital of Nanjing Medical University, Nanjing, China

    Qiuxia Chen, Aihua Zhang & Fei Zhao

  3. Department of Nephrology and Rheumatology, Shanghai Jiao Tong University Children’s Hospital, Shanghai, China

    Wenyan Huang, Ping Wang & Liwen Sun

  4. Department of Pediatrics, Peking University First Hospital, Beijing, China

    Huijie Xiao & Ke Xu

  5. Department of Nephrology, Beijing Children’s Hospital affiliated with Capital Medical University, Beijing, China

    Xiaorong Liu & Zhi Chen

  6. Department of Nephrology, Children’s Hospital Affiliated to Capital Institute of Pediatrics, Beijing, China

    Chaoying Chen & Juan Tu

  7. Department of Pediatric, Shengjing Hospital of China Medical University, Shenyang, China

    Yubin Wu & Xiuli Wang

  8. Department of Nephrology, Zhejiang University School of Medicine Children’s Hospital Binjiang Campus, Hangzhou, China

    Jianhua Mao, Zhihong Lu & Jingjing Wang

  9. Department of Pediatrics, 900th Hospital of PLA, Fuzhou, Fujian, China

    Xiaojing Nie & Jun Huang

  10. Department of Nephrology, Fuzhou Children’s Hospital of Fujian Medical University, Fuzhou, Fujian, China

    Zihua Yu

  11. Department of Nephrology and Rheumatology, Henan Children’s Hospital, Zhengzhou, Henan, China

    Cuihua Liu & Guanghai Cao

  12. Department of Pediatric Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China

    Yufeng Li & Yaju Zhu

  13. Department of Pediatrics, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China

    Jianjiang Zhang & Miao Wang

  14. Department of Nephrology and Rheumatology, Chongqing Medical University Affiliated Children’s Hospital, Chongqing, China

    Mo Wang & Haiping Yang

Authors
  1. Xiaoshan Tang
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  2. Qiuxia Chen
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Contributions

All authors meet all four of the International Committee of Medical Journal Editors’ (ICMJE) criteria for authorship: • Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; • Drafting the work or revising it critically for important intellectual content; • Final approval of the version to be published; • Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. X.T., Q.C. drafted the initial manuscript, carried out the initial analyses and and revised the manuscript. H.X., X.L., W.H., C.C., Y.W., J.M., X.N., C.L., Y.L., J.Z., M.W. revised the manuscript for important intellectual content. Z.Y., J.C., X.F., F.Z., P.W., L.S., K.X., Z.C., J.T., X.W., Z.L., J.W., J.H., G.C., Y.Z., H.Y. offered administrative, technical, or material support. A.Z., M.W. obtained the study funding. Q.S. and H.X. conceptualized and designed the study, had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Corresponding authors

Correspondence to Qian Shen or Hong Xu.

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Competing interests

The authors declare no competing interests.

Consent to participate

Written informed consent was obtained prior to the patient entering the study. The investigators explained the nature, purpose, and risks of the study to each patient/guardian. Each patient/guardian was informed that he/she could withdraw from the study at any time and for any reason. Each patient/guardian was given sufficient time to consider the implications of the study before deciding whether to participate. Patients/guardians who chose to participate signed an informed consent document.

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Tang, X., Chen, Q., Chen, J. et al. Growth hormone treatment in pre-pubertal short Chinese children with chronic kidney disease prior to transplantation. Pediatr Res 94, 268–274 (2023). https://doi.org/10.1038/s41390-022-02429-6

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  • DOI: https://doi.org/10.1038/s41390-022-02429-6

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