{"doi":"10.1159/000520186","title":"Lack of Evidence for Insulin Growth Factor I Treatment in Chronic Renal Insufficiency","abstract":"The benefit/risk ratio of GH use presented by Brown and Bauer (1) in their review encompass more than three decades. The information for GH us is solid but there is no data for recommending IGF-I use in CKD. Its main reference (2) is from the founder and chief technical officer the company that commercialized IGF-I, lacking any human data to support the use of IGF-I in this population questioning the validity of this endorsement. In 2005 IGF-I was approved in the US for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency or with GH gene deletion who have developed neutralizing antibodies to GH. Sixteen years have elapsed since and during this time four additional studies have been reported in clincilatrials.gov (3) and launched to explore the effects of IGF-I alone or in combination with GH in children with short stature of different etiologies. None of these studies included patients with CKD. The largest study, Treatment of Children and Adolescents with Growth Failure Associated with Primary IGF-1 Deficiency, was terminated by the sponsor “due to an unacceptably high incidence of hypoglycemia observed in approximately 50% of the subjects receiving 200 μg/kg rhIGF-1 or greater QD.” (3) Although the rationale for the dose escalation that almost doubled the original selection in successive amendments, is unknow to me, one can speculate that this was triggered by the desire to induce a more potent growth response given the well-known limited ability of IGF-I to stimulate growth acceleration-the end point of the study-, when compared with GH. It is worth highlighting that CKD associated short stature has received an orphan drug designation by the US FDA. As a result, the incentives for commercialization, given the high price of this drug, are extremely enticing. Additionally, FDA approval for rare conditions for a drug that is commercially available may have a lower hurdle. Moreover, an IGF-I indication for CKD has an enormous potential for profit given that CKD is much more prevalent (~10,000 patients in the US alone) than the only current limited indication (in the hundreds worldwide). In this context, I will argue that given the lack of any data showing benefit in children using IGF-I for CKD and the paucity of reliable scientific information in this area, it may be more appropriate not to advocate for the use of IGF-I for this purpose until data from human studies are generated","journal":"Hormone Research in Paediatrics","year":2021,"id":212278,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9518,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":460706,"name":"Saúl Malozowski","orcid":"0000-0003-2029-3050","position":0,"is_corresponding":true}],"reference_count":2,"raw_metadata":null,"created_at":"2026-07-18T23:52:27.434608Z","pmid":"34644711","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}