Clinical trial: A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Short Stature Children Due to Chronic Kidney Disease Before Transplantation (NCT03535415)

Eligibility criteria:
Inclusion Criteria:

          -  Signed informed consent of the subjects or the legal guardian.

          -  Subjects and guardian are willing and able to cooperate to complete scheduled
             visits,treatment plans and laboratory tests and other procedures.

          -  Diagnosed as chronic kidney disease.

          -  Glomerular filtration rate (GFR) <75ml/per min/1.73m2.

          -  After the treatment and adjustment of hypertension, anemia, metabolic acidosis,
             malnutrition, renal osteopathy, hypothyroidism, etc..

          -  Chronological age: ≥2years and ≤14years.

          -  Height Standard Deviation Score(HtSDS) ≤-2SD for chronological age.

          -  Bone age: girls≤10 years; boys≤11years.

          -  Pre-pubertal (Tanner Stage I ) patients.

          -  No history of growth hormone treatment.

        Exclusion Criteria:

          -  Subjects with abnormal liver functions.

          -  Subjects positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests.

          -  After adjustment heart function,Cardiac ejection fraction(EF) <50%.

          -  Subjects with highly allergic constitution or allergy to proteins or investigational
             product or its excipient.

          -  Subjects with systemic chronic disease or general infection or mental disease.

          -  Subjects with diabetes or impaired fasting glucose.

          -  Subjects with tumor or potential tumor.

          -  Subjects who are using glucocorticoid or immunosuppressant.

          -  Other causes for growth retardation.

          -  Inability to obtain accurate height measurements.

          -  Subjects who took part in other clinical trials within 3 months.

          -  Concomitant administration of other treatment that may have an effect on growth within
             3 months.

          -  Other conditions which are unsuitable for this study in the opinion of the
             investigator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 14 Years

Patient description (medical language): A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable.

Patient description (patient's own words): I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine.

Does the patient match the trial criteria? Contradiction