Recruiting

Observational Study

Sponsor:

The Hospital for Sick Children

Code:

NCT06153147

Conditions

Childhood Cancer

Chronic Kidney Diseases

Hypertension

Acute Kidney Injury

Nephrotoxicity

Eligibility Criteria

Sex: All

Age: 0 - 19

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Background: Childhood cancer survivors (CCS) are at elevated risk of chronic health conditions. Chemotherapies can cause recurrent acute kidney injury which may progress to kidney fibrosis, chronic kidney disease (CKD) or hypertension (HTN). CCS surviving to adulthood are at ≥3 times the risk (vs. non-CCS) for CKD, HTN and lower quality of life. However, the timing of CKD and HTN onset in CCS completing cancer therapy in childhood remains unclear.

Guidelines provide recommendations on managing post-cancer therapy effects in CCS, but they lack specificity on kidney testing content, frequency and complications. This discord is largely due to knowledge gaps on which CCS develop CKD or HTN after cancer therapy, when outcomes occur and their severity. Existing work has shown in select patients, CKD and HTN in CCS likely begins in the first 5 years post-cancer therapy and that the burden is significant. With robust data on CKD and HTN, international CCS follow-up guidelines can be optimized to include detailed and actionable recommendations on kidney and blood pressure monitoring and treatment.

Conditions

Childhood Cancer

Chronic Kidney Diseases

Hypertension

Acute Kidney Injury

Nephrotoxicity

Study ID

NCT06153147

Start date

Jan 5, 2024

Status verified date

Apr, 2024

Completion date

Dec 31, 2039

Anticipated

Primary completion date

Oct 25, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 19

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 3 years ± 6 months after therapy for first cancer
  • Received high-risk therapy for first cancer, as defined by the Canadian Oncology Group (COG) as alkylating agents; platinums; abdominal or total body radiation; high dose methotrexate; stem cell transplant; nephrectomy; or other therapy which may be known to possibly cause late kidney and/or BP effects.

Exclusion Criteria:

  • Pre-cancer severe CKD and/or previous kidney transplant
  • >19 years old at 3 years after cancer therapy completion

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Late effects after nephrotoxic chemotherapies.

3 and 5 year kidney and blood pressure effects after cancer therapy.

Primary outcome measure

  • Prevalence of Chronic Kidney Disease (CKD) based on eGFR (using an equation) at 3 years post cancer therapy [ Time Frame: 3 years +/- 6 months after cancer therapy end ]
  • Prevalence of Chronic Kidney Disease (CKD) based on eGFR (using an equation) at 5 years post cancer therapy [ Time Frame: 5 years +/- 6 months after cancer therapy end ]
  • Prevalence of Hypertension (HTN) from office blood pressure (vis blood pressure machine) at 3 years post cancer therapy [ Time Frame: 3 years +/- 6 months after cancer therapy end ]
  • Prevalence of Hypertension (HTN) using Ambulatory Blood Pressure Measurement (ABPM) at 5 years post cancer therapy [ Time Frame: 5 years +/- 6 months after cancer therapy end ]
  • Change in markers of kidney health (eGFR)(using an equation) between 3 and 5 years post cancer therapy [ Time Frame: Change from 3 to 5 years in eGFR ]
  • Change in markers of kidney health (Albuminuria) (using lab values) between 3 and 5 years post cancer therapy [ Time Frame: Change from 3 to 5 years in Albuminuria ]
  • Change in markers of kidney health (Proteinuria) (using Lab values) between 3 and 5 years post cancer therapy [ Time Frame: Change from 3 to 5 years in Proteinuria ]
  • Change in markers of cardiovascular health (using blood tests) between 3 and 5 years post cancer therapy [ Time Frame: Change from 3 to 5 years ]

Central Contacts and Locations

Central contacts

Michael Zappitelli, MD

4168137605michael.zappitelli@sickkids.ca

Yasmine Hejri-Rad, BA

416-813-7605yasmine.hejri-rad@sickkids.ca

Locations

The Hospital For Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1E8

Contacts

Yasmine Hejri-Rad, BA

416-813-7910yasmine.hejri-rad@sickkids.ca

Salma Abrahim, MSc

salma.abrahim@sickkids.ca

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Apr 17, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2024-04-17.