chronic kidney disease
Conditions
Interventions
Randomize patients with CKD and hypozincemia who are not receiving renal replacement therapy to the Nobelzin group or the control group
Sponsors
Itano Seiji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20 years or older 2) Patient whose most recent clinical tests performed within 12 weeks prior to enrollment meet all of the following criteria eGFR less than 60 ml/min/1.73 m2 serum zinc level less than 60 micro g/dl 3) Patient who provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Patient with a serum copper concentration of less than 60 micro g/dl on the most recent laboratory tests performed within 12 weeks prior to enrollment 2) Patient who continuously receives hemodialysis and peritoneal dialysis 3) Patient with kidney transplantation 4) Patient with active cancer, and receiving antineoplastic agent 5) Patient with a history of upper gastrointestinal resection 6) Patient with a history of allergy or anaphylaxis of the Zinc-containing preparation 7) Patient who receives the Zinc-containing preparation or the Zinc-containing supplement within 4 weeks prior to enrollment 8) Patient who are pregnant or breastfeeding 9) Patient deemed ineligible for the study by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint of renal replacement therapy (hemodialysis [HF, HDF, HD] or PD, or kidney transplantation), eGFR 40% or more decline from baseline ,doubling of serum Cr or death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes from baseline clinical laboratory values (Zn/Cu/eGFR/Alb/Hb/urine protein/urine albumin) at each study visit 2) The composite of initiation of hemodialysis or peritoneal dialysis 3) Kidney transplantation 4) 40% reduction of eGFR at each study visit 5) Doubling of serum creatinine 6) Death from cardiovascular causes, infectious causes, and other cause 7) Changes in dosage of ESA 8) Changes in symptoms of hypozincemia 9) Subgroup analysis according to characteristics of patients at baseline | — |
Contacts
Public ContactSeiji Itano
Kawasaki Medical School Hospital
Outcome results
None listed