NCT02225886

Brief Summary

The administration of ascorbic acid seemed to increase the iron available for erythropoiesis, thus improving the anemia response to the treatment. The investigators therefore aimed to evaluate the effects of intravenous ascorbic acid administration in hemodialysed patients with iron overload.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
5.4 years until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

3.1 years

First QC Date

August 23, 2014

Last Update Submit

February 21, 2020

Conditions

Anaemia Response to the TreatmentPeripheral Iron IndicesOxalemia

Keywords

Renal anaemiaIntravenous ascorbic acidIntravenous iron administration

Outcome Measures

Primary Outcomes (1)

  • Variation of erythropoetin resistance index (ERI)

    Erythropoietin resistance index: the dose of ESA divided by the level of Hb - will be calculated monthly.

    12 months

Secondary Outcomes (11)

  • Percentage of patients with Hb in the target range

    12 months

  • Changes in ESA dose

    12 months

  • Variation in ESA dose

    12 months

  • Variation of iron dose

    12 months

  • Percentage of patients with hemoglobin within target

    12 months

  • +6 more secondary outcomes

Study Arms (2)

Ascorbic acid

EXPERIMENTAL

Patients will receive a 300 mg intravenous ascorbic acid, 3 times a week, postdialysis, except for the dialysis sessions when iv iron is administered.

Drug: Ascorbic Acid

Control group

PLACEBO COMPARATOR

Patients will receive 100 mL saline solution, 3 times a week, with associated medication, except but the dialysis sessions when iv iron is administered.

Drug: Ascorbic Acid

Interventions

Ascorbic AcidDRUG

300 mg of intravenous ascorbic acid will be given 3 times a week, postdialysis, in 100 mL saline solution, except for the dialysis sessions when iv iron is administered

Ascorbic acidControl group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age above 18 years old
  • At least 6 months on hemodialysis at the time of randomization;
  • Kt/V≥1.2;
  • average of the last three serum ferritin levels \> 500 ng/mL AND
  • Average of the last three TSAT levels \> 20% and increasing
  • ERI in the 4th quartile of the group

You may not qualify if:

  • Active bleeding or other cause of anemia
  • Serum level of intact parathyroid hormone (iPTH)\>800 pg/mL
  • Actual neoplasia
  • HIV, Hepatitis B or C infections
  • Significant inflammation (CRP\>12mg/L) or acute infection
  • Venous central catheter
  • Severe hepatic, cardiovascular, psychic disease or other severe comorbidities
  • Moderate or severe malnutrition
  • Blood transfusions in the 2 months prior to screening
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Nefrolab" Dialysis Center

Slatina, Romania

RECRUITING

Related Publications (1)

  • Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

    PMID: 37916745DERIVED

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Gabriel Mircescu, Professor

    Anemia Working Group Romania

    STUDY CHAIR

  • Liliana Garneata, MD, PhD

    Anemia Workiing Group Romania

    STUDY DIRECTOR

  • Tudor Simionescu, MD, PhD

    "Carol Davila" Teaching Hospital of Nephrology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liliana Garneata, MD, PhD

CONTACT

+40722619358liliana.garneata@gmail.com

Tudor Simionescu, MD PhD

CONTACT

+40732161766tudorsimi@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2014

First Posted

August 26, 2014

Study Start

February 1, 2020

Primary Completion

March 1, 2023

Study Completion

December 1, 2023

Last Updated

February 24, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Publication

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
24 months

Locations

RO(1)