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RecruitingNCT04217512Updated Jan 3, 2020

Pantoprazole in Cisplatin Nephrotoxicity

A Phase 3 interventional study of Pantoprazole low dose and Pantoprazole high dose in Oncology, sponsored by Sherief Abd-Elsalam. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2020-01-03.

Sponsored by Sherief Abd-Elsalam · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled May 2019, registered Dec 2019).
  • Started May 2019; still recruiting 7 years 6 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
All
01

Study summary

Pantoprazole in Cisplatin Nephrotoxicity

Read the detailed description

Pantoprazole in Cisplatin NephrotoxicityPantoprazole in Cisplatin Nephrotoxicity. Is it protective?

02

Conditions studied

  • Oncology

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03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Sherief Abd-Elsalam is the lead sponsor of 50 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with head and neck cancer

Exclusion criteria

Exclusion Criteria:

  • less than 59.
  • DM
  • Elevated liver enzymes more than 3 fold.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Standard hydration alone

    Cisplatin with standard hydration

    Other: Standard hydration · Drug: Cisplatin

  • Active comparator
    Pantoprazole high dose

    Cisplatin with standard hydration with pantoprazole 1.6 mg/kg

    Drug: Pantoprazole high dose · Other: Standard hydration · Drug: Cisplatin

  • Active comparator
    Pantoprazole Low dose

    Cisplatin with standard hydration with pantoprazole 0.6 mg/kg

    Drug: Pantoprazole low dose · Other: Standard hydration · Drug: Cisplatin

Interventions

  • DrugPantoprazole low dose

    Pantoprazole 0.6 mg/kg

    Also known as: zurcal

  • DrugPantoprazole high dose

    Pantoprazole 1.6 mg\\kg

    Also known as: zurcal, Controloc

  • OtherStandard hydration

    Standard hydration alone

    Also known as: Hydration

  • DrugCisplatin

    Cisplatin

06

What researchers measure

Primary outcomes

  1. Number of patients with no renal toxicity

    The number of patients with no renal toxicity

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2019 (actual). Primary completion is estimated for Dec 2030, 139 months after the start.

Of 83 non-industry phase 3 interventional studies under Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 96. This study's planned 139 months is above that.

Counting every sponsor, half of 202 studies reached it within 50 months; a quarter within 33 and three quarters within 84.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 29, 2019
First posted
Jan 3, 2020
StartActual
May 1, 2019
Primary completionEst.
Dec 1, 2030
CompletionEst.
Dec 30, 2030
Last update
Jan 3, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04217512
Lead sponsor
Sherief Abd-Elsalam
Responsible party
Sherief Abd-Elsalam (Ass. Prof. Tropical Medicine, Tanta University) — Sponsor-investigator
First posted
Jan 3, 2020
Start date
May 1, 2019
Primary completion
Dec 1, 2030 (estimated)
Completion
Dec 30, 2030 (estimated)
Last update
Jan 3, 2020

Study contacts

Sherief Abd-Elsalam, ass. prof.
Contact
sheriefabdelsalam@yahoo.com
00201147773440
Eman M Ghonaim, Msc
principal investigator · Demonstrator of Clinical Pharmacy
Sahar El-Haggar, Prof
principal investigator · faculty of pharmacy Tanta University
Suzy Goher, Lecturer
principal investigator · faculty of pharmacy Tanta University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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