NCT06218212

Brief Summary

This clinical trial will evaluate Renastart formula effectiveness in children with acute kidney injury (AKI) and acute on top of chronic kidney disease (CKD), in maintaining normal serum electrolytes levels without using electrolyte binders,24 patients will be recruited from Pediatric Nephrology Unit (PNU), Children's Hospital, Ain Shams University, they will be assigned randomly in to two arms, arm 1 including patients who will be treated by electrolytes binders, arm 2 including patients who will be treated by Renastart formula, after initial assessment serum electrolyte evaluation will be followed up monthly for 3 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

January 12, 2024

Last Update Submit

February 2, 2024

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effectiveness and tolerability of Renastart formula in children with AKI and acute on top of CKD to correct and maintain normal serum levels of electrolytes.

    serum electrolytes

    monthly for 3 months

Study Arms (2)

Arm 1 patients with AKI and acute on top of CKD who will be treated by electrolytes binders.

ACTIVE COMPARATOR

they will start calcium carbonate (phosphorus binder) with dosage 45-65 mg/kg/day orally with / or sodium polystyrene sulfonate (potassium binder) with dosage 0.5-1mg/kg/day orally.

Drug: calcium carbonate (phosphorus binder) with / or sodium polystyrene sulfonate (potassium binder) with dosage 0.5-1mg/kg/day orally.

Arm 2 patients with AKI and acute on top of CKD who will be treated by Renastart formula.

EXPERIMENTAL

* Renastart formula will be used with breast milk, standard infant formula or with diet. * Preparation: Adding one level scoop of Renastart to 30 ml water. * Renastart formula will be started to represent ¼ recommended daily allowance of daily caloric intake and the dose will be adjusted according to serum electrolyte levels.

Dietary Supplement: Renastart formula

Interventions

Renastart formulaDIETARY_SUPPLEMENT

* Renastart formula is an artificial formula is made by Vitaflo USA, Nestle Health Science Company. * Renastart formula preparation: Adding one level scoop of Renastart to 30 ml water. * Renastart formula will be used with breast milk, standard infant formula, standard pediatric infant feed and/ or mixed with diet. * Renastart formula dosage will be adjusted to be 1/4 Renastart and 3/4 breast milk, standard infant formula or standard pediatric infant daily caloric feed ratio. * Readjusting dosage ratio according to serum electrolytes levels especially potassium.

Arm 2 patients with AKI and acute on top of CKD who will be treated by Renastart formula.
calcium carbonate (phosphorus binder) with / or sodium polystyrene sulfonate (potassium binder) with dosage 0.5-1mg/kg/day orally.DRUG

calcium carbonate (phosphorus binder) in dosage of 45-65 mg/kg/day orally with / or sodium polystyrene sulfonate (potassium binder) in dosage of 0.5-1mg/kg/day orally.

Arm 1 patients with AKI and acute on top of CKD who will be treated by electrolytes binders.

Eligibility Criteria

Age1 Month - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants and Children with AKI and acute on top of CKD Suffering from hyperkalemia and/or hyperphosphatemia at Pediatric Nephrology Unit (PNU), Children's Hospital, Ain Shams University Hospitals.

You may not qualify if:

  • Patients are on dialysis.
  • Pediatric patients with coexisting another medical problems and different risk factors which can affect serum electrolytes such as: Constipation, high volume blood transfusion and Diabetes medications disrupt potassium balance e.g., ACEI, ARBS and Diuretics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine-Ain Shams University

Cairo, Abbasia, 1181, Egypt

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Calcium Carbonatepolystyrene sulfonic acid

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Haya E Ibrahim, MD

    lecturer of pediatrics,Faculty of Medicine, Ain shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of pediatrics

Study Record Dates

First Submitted

January 12, 2024

First Posted

January 23, 2024

Study Start

February 12, 2022

Primary Completion

March 30, 2023

Study Completion

June 30, 2023

Last Updated

February 5, 2024

Record last verified: 2024-02

Locations

EG(1)