The therapeutic effect of sirolimus on the size of renal angiomyolipoma

The therapeutic effect of sirolimus on the size of renal angiomyolipoma: A non-blind non-randomized single-group clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201108049311N9

Enrollment

Registered

2024-09-04

Start date

2024-10-22

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Renal angiomyolipoma (AML). Benign lipomatous neoplasm of kidney

Interventions

Intervention group: Receiving 3 mg oral Iranian sirolimus (2 mg in the morning and 1 mg in the evening) for 6 months.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with a definitive diagnosis of sporadic or syndromic AML Being referred to the Nephrology Clinic of Imam Reza Hospital Being indicated for treatment with Sirolimus

Exclusion criteria

Exclusion criteria: Unwillingness to participate in the study Pregnant women

Design outcomes

Primary

Measure	Time frame
The size of AML tumors based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1. Timepoint: 1, 3 and 6 months after the start of the intervention. Method of measurement: Imaging findings.;The side effects of long-term use of Sirolimus. Timepoint: 1, 3 and 6 months after the start of the intervention. Method of measurement: Checking for mucositis, skin rashes (maculopapular, acne, dry skin, eczema, skin color changes, or nail changes), interstitial pneumonitis, urinary tract infection, hyperglycemia, hyperlipidemia, hypophosphatemia, bone marrow damage (anemia, neutropenia, thrombocytopenia, and leukopenia), and other side effects including weakness, lethargy, change in sense of taste, anorexia, diarrhea, and nausea.;Kidney function in AML patients receiving Sirolimus. Timepoint: 1, 3 and 6 months after the start of the intervention. Method of measurement: Measurement of creatinine level and patient's baseline GFR.;The tolerance level of long-term use of Sirolimus. Timepoint: 1, 3 and 6 months after the start of the intervention. Method of measurement: Checking for mucositis, skin rashes (maculopapular, acne, dry skin, eczema, skin color changes, or nail changes), interstitial pneumonitis, urinary tract infection, hyperglycemia, hyperlipidemia, hypophosphatemia, bone marrow damage (anemia, neutropenia, thrombocytopenia, and leukopenia), and other side effects including weakness, lethargy, change in sense of taste, anorexia, diarrhea, and nausea.	—

Measure

Time frame

The size of AML tumors based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1. Timepoint: 1, 3 and 6 months after the start of the intervention. Method of measurement: Imaging findings.;The side effects of long-term use of Sirolimus. Timepoint: 1, 3 and 6 months after the start of the intervention. Method of measurement: Checking for mucositis, skin rashes (maculopapular, acne, dry skin, eczema, skin color changes, or nail changes), interstitial pneumonitis, urinary tract infection, hyperglycemia, hyperlipidemia, hypophosphatemia, bone marrow damage (anemia, neutropenia, thrombocytopenia, and leukopenia), and other side effects including weakness, lethargy, change in sense of taste, anorexia, diarrhea, and nausea.;Kidney function in AML patients receiving Sirolimus. Timepoint: 1, 3 and 6 months after the start of the intervention. Method of measurement: Measurement of creatinine level and patient's baseline GFR.;The tolerance level of long-term use of Sirolimus. Timepoint: 1, 3 and 6 months after the start of the intervention. Method of measurement: Checking for mucositis, skin rashes (maculopapular, acne, dry skin, eczema, skin color changes, or nail changes), interstitial pneumonitis, urinary tract infection, hyperglycemia, hyperlipidemia, hypophosphatemia, bone marrow damage (anemia, neutropenia, thrombocytopenia, and leukopenia), and other side effects including weakness, lethargy, change in sense of taste, anorexia, diarrhea, and nausea.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammadreza Ardalan

Tabriz University of Medical Sciences

ardalan34@yahoo.com+98 41 3337 3992

Outcome results

None listed

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