To evaluate the effect of renogrit in protecting kidneys from side effects of cisplatin in patients with advanced cancers.

A randomized clinical trial to assess the nephroprotective efficacy of renogrit in patients receiving Cisplatin based chemotherapy in advanced or metastatic solid tumors. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080059

Enrollment

220

Registered

2025-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: C39- Malignant neoplasm of other and ill-defined sites in the respiratory system and intrathoracic organs

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with evaluable disease, histologically documented confirmed diagnosis of solid malignancy of head and neck, lung and esophagus. 2. All patients planned for single agent cisplatin or its combination based chemotherapy at dose more than or equal to 75 mg/m2 3. ECOG performance status less than equal to 2 4. Patients who are administered only a full dose of cisplatin that is more than or equal to 75mg/m2. 5. Voluntarily signed informed consent. 6. Patient is ablee to swallow oral medication.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of chronic kidney disease (CKD) at baseline (glomerular filtration rate less than 60 mL/min/1.73m2 determined by Cockcorft-gault equation. 2. Past kidney transplant patients. 3. Previous use of any nephrotoxic drugs (e.g. aminoglycoside antibiotics, NSAIDs and any other drug which is potentially nephrotoxic including complementary alternative medicines) in the two weeks prior to initiation of Cisplatin (CisP) treatment. 4. Previous hematopoietic stem cell transplant 5. Any chronic or acute health condition that the investigator feels would render the patient inappropriate for this study, including but not limited to significant uncontrolled cardiorespiratory, hepatic, infectious, or renal disease at the discretion of the investigator 6. History hypersensitivity reaction (anaphylaxis, angioedema, exfoliated skin conditions). 7. Patients who receive fractionated dose of cisplatin will not be included in the study. 8. Patients requiring dose modification of cisplatin for any underlying condition. 9. Previous use of Cisplatin (CisP) based chemotherapy

Design outcomes

Primary

Measure	Time frame
To demonstrate the efficacy of Renogrit in the prevention of cisplatin induced nephrotoxicityTimepoint: Baseline, Cycle 1 Day 1 and 1 year after chemotherapy treatment.	—

Secondary

Measure	Time frame
1. To demonstrate the efficacy of Renogrit over standard supportive care in preventing deterioration of markers of kidney function (eGFR and serum NGAL) 2. To demonstrate the efficacy of Renogrit in delaying the time to Acute Kidney Injury over standard supportive care 3. To investigate the Incidence of proteinuria and electrolyte abnormalities (Mg/Ca) in the two arms 4. To demonstrate the efficacy of Renogrit over standard supportive care in decreasing the cumulative incidence of treatment interruptions 5. To evaluate the difference in EFS between the two arms 6. To demonstrate the efficacy of Renogrit over standard supportive care in improving overall quality of life (QoL) 7. To evaluate difference in pharmacokinetic profile of cisplatin between the two arms 8. To determine the incidence of treatment emergent adverse events (TEAE)Timepoint: Baseline, Cycle 1 Day 1 and 1 year after chemotherapy treatment.	—

Measure

Time frame

1. To demonstrate the efficacy of Renogrit over standard supportive care in preventing deterioration of markers of kidney function (eGFR and serum NGAL) 2. To demonstrate the efficacy of Renogrit in delaying the time to Acute Kidney Injury over standard supportive care 3. To investigate the Incidence of proteinuria and electrolyte abnormalities (Mg/Ca) in the two arms 4. To demonstrate the efficacy of Renogrit over standard supportive care in decreasing the cumulative incidence of treatment interruptions 5. To evaluate the difference in EFS between the two arms 6. To demonstrate the efficacy of Renogrit over standard supportive care in improving overall quality of life (QoL) 7. To evaluate difference in pharmacokinetic profile of cisplatin between the two arms 8. To determine the incidence of treatment emergent adverse events (TEAE)Timepoint: Baseline, Cycle 1 Day 1 and 1 year after chemotherapy treatment.

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Countries

India

Contacts

Public ContactDr Vikram Gota

ACTREC, Tata Memorial Centre

vikramgota@gmail.com02227405493

Outcome results