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The effect of N-Acetylcystein on prevention of Acute Renal injury due to Cyclosporine Administration in patients undergoing bone marrow transplantation

The effect of N-Acetylcystein on prevention of Acute Renal injury due to Cyclosporine Administration in patients undergoing bone marrow transplantation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201306031030N14
Enrollment
60
Registered
2013-06-06
Start date
2012-07-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: AML. Condition 2: ALL. Condition 3: Acute Renal injury. Acute myeloblastic leukaemia Acute lymphoblastic leukaemia

Interventions

Intervention 1: N-acetyl cysteine IV 100mg/kg daily. Drug start on the morning before starting chemotherapy and will continue until day 15 after transplantation. Intervention 2: Placebo Start on the m
Treatment - Drugs
Placebo
N-acetyl cysteine IV 100mg/kg daily. Drug start on the morning before starting chemotherapy and will continue until day 15 after transplantation.
Placebo Start on the morning before starting chemotherapy and will continue until day 15 after transplantation.

Sponsors

Hematology Oncology and SCT Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- Patients with acute myeloid leukemia or acute lymphocytic leukemia 2- Full match Allogeneic Bone Marrow Transplantation 3- Age between 15-60 year old 4- Treatment of Cyclosporin after transplantation Exclusion criteria: 1- Patient under 15 year old 2- Patient with diabetes, chronic kidney disease, liver disorder or hypertension

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Serum Creatinin. Timepoint: 6 and 3 days before transplantation and 3, 9 and 5 day after transplantation. Method of measurement: Lab test.

Secondary

MeasureTime frame
Urine NGAL. Timepoint: 6 and 3 days before transplantation and 3, 9 and 5 day after transplantation. Method of measurement: Lab test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSara Ataei

Hematology Oncology and SCT Research Center

horcbmt@tums.ac.ir+98 21 8490 2635

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026