NCT01817699

Brief Summary

The purpose of this study is to evaluate the effect of anemia correction and vitamin D supplementation in kidney transplant recipients.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
161

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

March 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

5.7 years

First QC Date

March 21, 2013

Last Update Submit

January 31, 2019

Conditions

Kidney TransplantationAnemiaVitamin D DeficiencyRenal Insufficiency, Chronic

Keywords

CholecalciferolMethoxy polyethylene glycol-epoetin betaHematinicsBone Diseases, MetabolicNeoplasmsCardiovascular DiseasesGraft Rejection

Outcome Measures

Primary Outcomes (1)

  • Change in allograft kidney function

    As allograft kidney function, GFR is estimated by the modified MDRD equation for Japanese patients with chronic kidney disease.

    2 years

Secondary Outcomes (13)

  • Urine markers of kidney injury

    6 months

  • The dose of methoxy polyethylene glycol epoetin beta required to maintain the target hemoglobin level

    1 year

  • Blood pressure

    2 years

  • Cardiac biomarkers

    2 years

  • Left ventricular mass index

    2 years

  • +8 more secondary outcomes

Other Outcomes (3)

  • C-reactive protein

    1 year

  • Time to the adverse composite endpoint

    2 years

  • Time to hospitalization for opportunistic infections

    2 years

Study Arms (4)

Low Hb target without cholecalciferol

NO INTERVENTION

Target Hemoglobin level: ≥9.5 and \<10.5 g/dL

Low Hb target with cholecalciferol

ACTIVE COMPARATOR

Target Hemoglobin level: ≥9.5 and \<10.5 g/dL Cholecalciferol: 1,000 IU/day

Dietary Supplement: cholecalciferol

High Hb target without cholecalciferol

ACTIVE COMPARATOR

Target Hemoglobin level: ≥12.5 and \<13.5 g/dL

Other: High Hb target

High Hb target with cholecalciferol

EXPERIMENTAL

Target Hemoglobin level: ≥12.5 and \<13.5 g/dL Cholecalciferol: 1,000 IU/day

Other: High Hb targetDietary Supplement: cholecalciferol

Interventions

High Hb targetOTHER

25 to 250 μg of methoxy polyethylene glycol epoetin beta (Mircera®, Chugai pharmaceutical Co. Ltd.) will be administered subcutaneously at 2- to 6-week interval. Dose and interval will be adjusted according to hemoglobin level and its target.

High Hb target with cholecalciferolHigh Hb target without cholecalciferol
cholecalciferolDIETARY_SUPPLEMENT

1,000 IU (1 tablet)/day, orally. Tablets are repacked into blister package.

Also known as: Super vitamin D (Nature Made®)
High Hb target with cholecalciferolLow Hb target with cholecalciferol

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥15 and \<60 ml/min per 1.73 m2 of estimated glomerular filtration rate
  • Transplanted allograft kidney at least 1 year before
  • \<10.5 g/dL of Hb without iron deficiency (serum ferritin level ≥50 ng/ml) or on erythropoiesis stimulating agents treatment regardless of iron status
  • With written informed consent

You may not qualify if:

  • On anticancer treatment
  • History of ischemic stroke or transient ischemic attack
  • Corrected serum calcium ≥10.5 mg/dL
  • HIV virus infection
  • Anticipated refractory hypertension by using epoetin beta pegol
  • In pregnancy and lactation
  • Current use of native vitamin D supplement
  • Patients ineligible according to the investigator's judgement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CANDLE Trial Study Group

Suita, Osaka, 565-0871, Japan

Location

Related Publications (5)

  • Choukroun G, Kamar N, Dussol B, Etienne I, Cassuto-Viguier E, Toupance O, Glowacki F, Moulin B, Lebranchu Y, Touchard G, Jaureguy M, Pallet N, Le Meur Y, Rostaing L, Martinez F; CAPRIT study Investigators. Correction of postkidney transplant anemia reduces progression of allograft nephropathy. J Am Soc Nephrol. 2012 Feb;23(2):360-8. doi: 10.1681/ASN.2011060546. Epub 2011 Dec 22.

    PMID: 22193388BACKGROUND

  • Gallagher JC, Sai A, Templin T 2nd, Smith L. Dose response to vitamin D supplementation in postmenopausal women: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):425-37. doi: 10.7326/0003-4819-156-6-201203200-00005.

    PMID: 22431675BACKGROUND

  • Matsuo S, Imai E, Horio M, Yasuda Y, Tomita K, Nitta K, Yamagata K, Tomino Y, Yokoyama H, Hishida A; Collaborators developing the Japanese equation for estimated GFR. Revised equations for estimated GFR from serum creatinine in Japan. Am J Kidney Dis. 2009 Jun;53(6):982-92. doi: 10.1053/j.ajkd.2008.12.034. Epub 2009 Apr 1.

    PMID: 19339088BACKGROUND

  • Stevens LA, Schmid CH, Zhang YL, Coresh J, Manzi J, Landis R, Bakoush O, Contreras G, Genuth S, Klintmalm GB, Poggio E, Rossing P, Rule AD, Weir MR, Kusek J, Greene T, Levey AS. Development and validation of GFR-estimating equations using diabetes, transplant and weight. Nephrol Dial Transplant. 2010 Feb;25(2):449-57. doi: 10.1093/ndt/gfp510. Epub 2009 Sep 30.

    PMID: 19793928BACKGROUND

  • Horio M, Imai E, Yasuda Y, Watanabe T, Matsuo S. Modification of the CKD epidemiology collaboration (CKD-EPI) equation for Japanese: accuracy and use for population estimates. Am J Kidney Dis. 2010 Jul;56(1):32-8. doi: 10.1053/j.ajkd.2010.02.344. Epub 2010 Apr 22.

    PMID: 20416999BACKGROUND

MeSH Terms

Conditions

AnemiaVitamin D DeficiencyRenal Insufficiency, ChronicBone Diseases, MetabolicNeoplasmsCardiovascular Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBone DiseasesMusculoskeletal DiseasesMetabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Takayuki Hamano, MD, PhD

    Department of Inter-Organ Communication Research in Kidney Disease, Osaka University Graduate School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2013

First Posted

March 25, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 4, 2019

Record last verified: 2019-01

Locations

JP(1)