Effectiveness of zinc acetate hydrate supplementation in chronic kidney disease patients

JRCT ID: jRCTs061210030

Registered date:27/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: chronic kidney disease
• Date of first enrollment: 07/01/2022
• Target sample size: 200
• Study type: Interventional
• Intervention(s): Randomize patients with CKD and hypozincemia who are not receiving renal replacement therapy to the Nobelzin group or the control group

Outcome(s)

• Primary Outcome: Composite endpoint of renal replacement therapy (hemodialysis [HF, HDF, HD] and PD, or kidney transplantation), eGFR 40% or more decline from baseline ,doubling of serum Cr or death from any cause

Secondary Outcome

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 and 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Itano Seiji
• Source(s) of Monetary Support: Nobel Pharma CO.,LTD.
• Secondary ID(s): Nil known